gh Remarks as Prepared for Delivery by Attorney General Holder at the Community Relations Service 50th Anniversary of the Civil Rights Act of 1964 Ceremony By www.justice.gov Published On :: Mon, 14 Jul 2014 15:44:04 EDT "We must recommit ourselves to the legacies of visionary leaders and courageous citizens who made the passage of the Civil Rights Act, and the creation of this agency, possible. And we must resolve to keep moving forward together – as one nation and one people – driven by the needs that remain unfulfilled, determined to transcend the barriers that still divide us, and dedicated to the enduring promise of equal justice under law." Full Article Speech
gh Attorney General Holder Delivers Remarks at Howard University for the 50th Anniversary Celebration of the Civil Rights Act By www.justice.gov Published On :: Tue, 15 Jul 2014 10:26:33 EDT That, at its core, is what defines us as Americans: a people born of revolution and tested by civil war. A nation founded on equality but built by those in chains. A country first imagined, centuries ago, by imperfect people driven by a near-perfect vision – a vision conceived by patriots who dared to reach beyond themselves and defended later by activists who fought for equal justice – and who challenge us, even today, to make this promise real. Full Article Speech
gh Associate Attorney General Tony West Delivers Remarks at Howard University for the 50th Anniversary Celebration of the Civil Rights Act By www.justice.gov Published On :: Tue, 15 Jul 2014 18:06:27 EDT Today, we are privileged to be joined by two national leaders who have worked tirelessly to "pay it forward" by devoting their lives to promoting justice, fairness, and equality. Full Article Speech
gh Deputy Attorney General James M. Cole Delivers Remarks at the 50th Anniversary of the Civil Rights Act of 1964 Howard University Event By www.justice.gov Published On :: Wed, 16 Jul 2014 13:58:08 EDT History is not just a series of events; it is the people who create those events. It is the impact of the stories—told and untold—of the many trailblazers and unsung heroes whose tireless sacrifices and relentless dedication have resulted in justice, equality, opportunity, and freedom for all. Full Article Speech
gh Testimony by Deputy Attorney General James M. Cole Before the Subcommittee on Economic Growth, Job Creation and Regulatory Affairs Committee on Oversight and Government Reform By www.justice.gov Published On :: Mon, 15 Sep 2014 09:47:19 EDT We recognize the Committee’s interest in this matter. We share that interest and are conducting a thorough and complete investigation and analysis of the allegations of targeting by the IRS. While I know you are frustrated by the fact that I cannot at this time disclose any specifics about the investigation, I do pledge to you that when our investigation is completed, we will provide Congress with detailed information about the facts we uncovered and the conclusions we reached in this matter Full Article Speech
gh Unlicensed Trader Pleads Guilty in Los Angeles for Role in Fraudulent High Yield Investment Program Scheme By www.justice.gov Published On :: Fri, 29 Aug 2014 14:20:30 EDT An unlicensed trader who solicited $500,000 from undercover FBI agents to invest in a fraudulent high yield investment program pleaded guilty today in federal court in Los Angeles Full Article OPA Press Releases
gh French Citizen Sentenced for Obstructing a Criminal Investigation into Alleged Bribes Paid to Win Mining Rights in Guinea By www.justice.gov Published On :: Fri, 29 Aug 2014 14:53:12 EDT Frederic Cilins, a 51-year old French citizen, was sentenced today in the Southern District of New York to 24 months in prison for obstructing a federal criminal investigation into alleged bribes to obtain mining concessions in the Republic of Guinea Full Article OPA Press Releases
gh Attorney General Holder Announces Justice Department Filings in Voting Rights Cases in Wisconsin and Ohio By www.justice.gov Published On :: Fri, 29 Aug 2014 09:41:55 EDT Attorney General Eric Holder announced today that the Justice Department has submitted filings in voting rights cases in Wisconsin and Ohio. The department’s involvement in these two cases represents its latest steps to enforce the remaining parts of the Voting Rights Act against restrictive state laws, following up on the department’s lawsuits last year against similar measures in Texas and North Carolina Full Article OPA Press Releases
gh Former Employee of a U.S. Construction Company Working in Afghanistan Pleads Guilty to Receiving Illegal Kickback By www.justice.gov Published On :: Fri, 29 Aug 2014 09:39:33 EDT A former project manager of a U.S. construction company working on U.S. government contracts in Afghanistan who solicited a $60,000 kickback from an Afghan subcontractor pleaded guilty today in federal court in Tucson, Arizona Full Article OPA Press Releases
gh U.S. Attorney for the Southern District of New York Finds Pattern and Practice of Excessive Force and Violence at New York City Jails on Rikers Island That Violates the Constitutional Rights of Adolescent Male Inmates By www.justice.gov Published On :: Thu, 28 Aug 2014 15:30:54 EDT Attorney General Eric Holder and United States Attorney for the Southern District of New York Preet Bharara announced today the completion of the Justice Department’s multi-year civil investigation pursuant to the Civil Rights of Institutionalized Persons Act (“CRIPA”) into the conditions of confinement of adolescent male inmates on Rikers Island. The investigation, which focused on use of force by staff, inmate-on-inmate violence, and use of punitive segregation during the period 2011-2013, concluded that there is a pattern and practice of conduct at Rikers Island that violates the rights of adolescents protected by the Eighth Amendment and the Due Process Clause of the Fourteenth Amendment of the United States Constitution. The investigation found that adolescent inmates are not adequately protected from physical harm due to the rampant use of unnecessary and excessive force by New York City Department of Correction (“DOC”) staff and violence inflicted by other inmates Full Article OPA Press Releases
gh Two North Carolina Residents Plead Guilty to Defrauding Elderly Through Offshore Sweepstakes Scheme By www.justice.gov Published On :: Thu, 28 Aug 2014 15:29:41 EDT A North Carolina couple pleaded guilty for leading a Costa Rican sweepstakes fraud scheme that defrauded hundreds of elderly Americans Full Article OPA Press Releases
gh Six Alleged Members of the Almighty Imperial Gangsters Nation Gang Indicted By www.justice.gov Published On :: Thu, 28 Aug 2014 15:28:38 EDT Five alleged members of the violent Almighty Imperial Gangsters Nation gang have been indicted by a federal grand jury in the Southern District of Florida for their roles in multiple murders. A sixth alleged gang member was indicted for unlawfully possessing a firearm Full Article OPA Press Releases
gh U.S. Forfeits Over $480 Million Stolen by Former Nigerian Dictator in Largest Forfeiture Ever Obtained Through a Kleptocracy Action By www.justice.gov Published On :: Thu, 28 Aug 2014 15:13:28 EDT The Department of Justice has forfeited more than $480 million in corruption proceeds hidden in bank accounts around the world by former Nigerian dictator Sani Abacha and his co-conspirators Full Article OPA Press Releases
gh The following joint statement was released Friday by FBI Special Agent in Charge William P. Woods, U.S. Attorney for the Eastern District of Missouri Richard G. Callahan and Acting Assistant Attorney General for the Civil Rights Division Molly Moran By www.justice.gov Published On :: Thu, 28 Aug 2014 14:18:32 EDT The former chief executive officer of Hanover Corporation was sentenced today to serve 14 years in prison, to be followed by three years of supervised release and ordered to pay $14,784,983.75 in restitution for orchestrating an $18 million Ponzi scheme Full Article OPA Press Releases
gh Statement by Justice Department Spokesman on Latest Developments in Federal Civil Rights Investigation in Ferguson, Missouri By www.justice.gov Published On :: Thu, 28 Aug 2014 14:16:05 EDT The following statement was released Sunday by Justice Department spokesman Brian Fallon concerning the federal civil rights investigation into the shooting of Michael Brown in Ferguson, Missouri Full Article OPA Press Releases
gh Attorney General Statement on Latest Developments in Federal Civil Rights Investigation in Ferguson, MO By www.justice.gov Published On :: Thu, 28 Aug 2014 14:09:43 EDT Attorney General Eric Holder released the following statement Monday following his briefing of President Obama on the latest developments in the federal civil rights investigation in Ferguson, Missouri Full Article OPA Press Releases
gh Eight Alleged Members and Associates of the Two Six Nation Street Gang Indicted for Racketeering Conspiracy By www.justice.gov Published On :: Thu, 28 Aug 2014 13:36:42 EDT Four members of the Two Six Nation street gang and four of their associates have been indicted for their roles in a racketeering conspiracy spanning more than 20 years, as well as murder and drug trafficking charges Full Article OPA Press Releases
gh Six Former Puerto Rico Police Officers Plead Guilty to Federal Civil Rights, Obstruction of Justice and Perjury Charges By www.justice.gov Published On :: Thu, 28 Aug 2014 13:24:35 EDT Three Puerto Rico police officers, Erick Rivera Nazario, Angel Torres Quinones and Antonio Rodriguez Caraballo today pleaded guilty to federal civil rights charges in connection with the fatal beating of 19-year-old Jose Luis Irizarry Perez, announced Acting Assistant Attorney General Molly Moran for the Civil Rights Division, United States Attorney Rosa Emilia Rodriguez-Velez for the District of Puerto Rico, and Special Agent in Charge Carlos Cases of the FBI San Juan Field Office. Full Article OPA Press Releases
gh Disc Jockey for High School Parties Sentenced to 40 Years in Prison for Sexually Exploiting Three Minors By www.justice.gov Published On :: Thu, 28 Aug 2014 17:58:12 EDT Eduardo Santiago-Rivera, 45, admitted that in June and July 2012, he caused at least three minors, who ranged in age from 12 to 15, to engage in sexual activity for the purpose of creating videos. Full Article OPA Press Releases
gh Justice Department Participates in Child Cyber Safety Night at Nationals Park, Saturday, September 6th By www.justice.gov Published On :: Fri, 5 Sep 2014 14:13:32 EDT Child Cyber Safety Night at the Ballpark is the latest effort by the Justice Department and its law enforcement and community partners to encourage parents to speak with their children about online and cell phone safety and provide prevention materials. Full Article OPA Press Releases
gh Owner of Costa Rican Call Center Pleads Guilty to Defrauding Elderly Through Sweepstakes Scam By www.justice.gov Published On :: Mon, 15 Sep 2014 13:00:25 EDT A dual United States-Costa Rican citizen pleaded guilty today for his role in a $1.88 million sweepstakes fraud scheme that defrauded hundreds of elderly Americans. Full Article OPA Press Releases
gh SAVA Gets Funding For AD Drug, JNJ Hits All-time High, ENZ On Watch By www.rttnews.com Published On :: Fri, 24 Apr 2020 05:43:19 GMT Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate. Full Article
gh CYCC In STOPCOVID, EXEL Hits New High, NVS Trialing Malaria Drug For COVID-19 By www.rttnews.com Published On :: Tue, 21 Apr 2020 05:39:42 GMT Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19. Full Article
gh Relmada Therapeutics (RLMD): Sending The Right Signals? By www.rttnews.com Published On :: Tue, 28 Apr 2020 10:46:01 GMT Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37. Full Article
gh BPMC's VOYAGER Fails, CLSD's NDA Resubmission Faces Delay, SNDX Hits New High By www.rttnews.com Published On :: Wed, 29 Apr 2020 04:59:15 GMT Today's Daily Dose brings you news about Blueprint Medicines' disappointing results from gastrointestinal stromal tumor trial; revised timeline of Clearside Biomedical's resubmission of XIPERE NDA; encouraging trial results of INOVIO's MERS coronavirus vaccine and initial data from Syndax Pharma's acute leukemia trial. Full Article
gh BASF Launches Breakthrough Absorption Technology as GOED Raises Bioavailability Challenge to Omega-3 Industry By feedproxy.google.com Published On :: Mon, 05 Feb 2018 18:39:00 GMT BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements. Full Article
gh Parry Nutraceuticals, Valensa Expand Microalgae Plans Through Joint Venture with Synthite Industries By feedproxy.google.com Published On :: Mon, 05 Feb 2018 20:57:00 GMT Valensa International announced today a joint venture agreement between Valensa’s parent company EID Parry and Synthite Industries Ltd., expanding plans to lead development and distribution of value-added microalgae extracts. Full Article
gh Recent Weight Management Ingredient Research Reflects Emerging Trends By feedproxy.google.com Published On :: Thu, 08 Feb 2018 15:22:00 GMT Emphasis on fat and protein intake, reduced carbohydrate intake and gut health for managing weight are trends affecting the global weight management category. Full Article
gh DSM Insight Series: 1 in 4 Consumers Prepare, Consume Breakfast in Less Than 5 Minutes By feedproxy.google.com Published On :: Thu, 08 Feb 2018 16:24:00 GMT DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US. Full Article
gh New Study Highlights OptiMSM's Influence on Key Metabolic Reactions By feedproxy.google.com Published On :: Thu, 08 Feb 2018 22:09:00 GMT Bergstrom Nutrition, manufacturer of OptiMSM®, a branded form of methylsulfonylmethane (MSM), recently published an article detailing how the small intestine absorbs MSM, particularly in relation to sulfur. Full Article
gh A Thoughtful Innovation: HP Ingredients Launches Quantum IQ for Cognitive Health By feedproxy.google.com Published On :: Mon, 12 Feb 2018 22:39:00 GMT The cognitive-boost market just received another potent supplement ingredient–Quantum IQ Polygonum minus extract, exclusively from HP Ingredients, Inc. (HPI). Full Article
gh Sunlight exposure and its role in skin-gut axis By www.nutraingredients-usa.com Published On :: Mon, 04 May 2020 17:18:00 +0100 Outside influences have shown strong correlations with what lives inside our bodies, and researchers are just beginning to understand how these environmental factors may affect the makeup of the gut microbiome. Full Article Research
gh Active nutrition and immunity: Getting the right balance By www.nutraingredients.com Published On :: Wed, 06 May 2020 10:58:00 +0100 Exercise is good for the immune system but, as with anything, balance is key and this is especially the case when it comes to matching the type and level of activity with the right nutrition, as will be expertly explained in NutraIngredients' upcoming webinar. Full Article Views
gh APEC SME Ministers Commit to Inclusion Through Digital Transformation By www.apec.org Published On :: Fri, 06 Sep 2019 00:10:00 +0800 Ministers convened this week in Concepcion to talk about one of the most underrepresented but vital business sectors of the region. Full Article
gh Empower Women to Fight Corruption: Dr Wan Azizah By www.apec.org Published On :: Thu, 13 Feb 2020 18:03:00 +0800 The impact of corruption is far-reaching and devastating, especially for women. Full Article
gh RE: UV Light Sterilizers By connect.raps.org Published On :: Fri, 08 May 2020 05:46:56 -0400 From : Communities>>Regulatory Open ForumHi, Willard - The Product code RHP won't show any 510(k)s because that is not a match for any regulated medical device. You can see the classification in the "Radiation Emitting Electronic Product Codes" page (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm?PCD=RHP), where it also notes that for this Product Code, there are no applicable standards for these "UV Lamp, Germicidal" products. If it were a medical device, it might fall under FDA's classification for certain [More] Full Article Discussion
gh RE: UV Light Sterilizers By connect.raps.org Published On :: Sat, 09 May 2020 09:57:33 -0400 From : Communities>>Regulatory Open ForumGood morning, Willard. In the U.S., disinfectants fall under the jurisdiction of both the FDA and EPA. The agencies have an MOU in place to better define there roles. Accordingly, devices that are intended for "trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals). . ." are defined as "pesticide devices", under FIFRA section 2(h),. Pesticide [More] Full Article Discussion
gh Love at First "Site": Early Signs of Strong PI Oversight By polarisconsultants.blogspot.com Published On :: Sun, 12 Nov 2017 15:07:00 +0000 When I was a teenager, my grandfather would invite my new boyfriends to run short, pointless errands with him, just so he could watch them drive. He said he could tell a lot about a boy’s character simply by observing his actions behind the wheel. Did he stay under the speed limit? Did he use his signal when he was switching lanes? Did he slow down when children were playing near the road? If so, it was a good sign that the boy was generally a careful and attentive fellow. If not, it was an early indication of reckless tendencies, and I would do well to be on my guard.What does this have to do with PI oversight?As Sponsors and CROs, you’re sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be – hope to be – reflective of the site as a whole. In a short space of time, you need to assess a PI’s commitment to study oversight. On what should your pre-study “test drive” focus to help you gauge the level of care and attention a prospective PI will devote to your study?We have some suggestions. Assessing Attention to DetailAny GCP-compliant site can produce a set of current CVs, job descriptions, and training records; they’re essential documents. But the most attentive sites are able to show you more than a collection of records during your pre-study visit with them. These sites keep a complete, organized set of uniform records and can describe their tight system for maintaining it. All documents for each staff member are found in dedicated tabs inside a records binder, or are equally well-organized in an electronic records system. All CVs are in a standard format so Sponsors can easily compare qualifications across individuals. Every document is current; CVs are up to date, and there’s a system in place to track which medical licenses are expiring when. Training records are comprehensive and include training on GCP regulations, site SOPs, and EMRs.This is not sexy stuff. That’s why it’s a good indicator of PI oversight. A site that is disciplined enough to keep such tight control over its personnel records is likely to carry that control into all aspects of trial execution.Assessing Commitment to Protocol ComplianceDuring site initiation visits, Sponsor/CRO staff is on site to conduct protocol training; all study sites start off the same in this respect. But protocol amendments are inevitable, and sometimes – though nobody’s happy about it – frequent. You need assurances that a site’s response to each amendment will be swift, well-coordinated, and deliberate. Ask the prospective PI, “What procedures does your site follow for managing protocol amendments?”The A answer:“When a protocol amendment arrives, we convene a special team meeting to review the changes and discuss their effects. For example, if additional safety tests are required, the team discusses who shall be delegated to perform them? Do we have adequate time scheduled into the visit for any additional procedures the amendment requires? How will I be demonstrating oversight of any new test results? Once we’ve asked and answered these kinds of questions, we document attendance at the meeting, record assignments of delegated duties, and publish meeting minutes.”The F answer:“I email the amendment out to my team. I assume they’re all adults and know how to read.” (#TrueStory)Just AskAfter reviewing essential documents and protocol amendment procedures, you should ask about other PI oversight mechanisms the site has in place. A good prospective site might tell you the PI holds biweekly meetings to review the items raised during monitoring visits. A PI may block out time at regular intervals to review adverse events and other study documents, and sign off on labs. A PI who values staff excellence may actively encourage and support Study Coordinator certification; some may even require it after an initial period of employment. In the past, we’ve worked with sites that have established internal Quality Control procedures, some maintain CAPA programs, and others conduct mock inspections.There’s a wide variety of responses that can give you confidence a prospective PI is committed to running your study in a constant state of control. Whatever oversight measures are discussed, remember to ask how they will be documented, so during the study you’ll be able to verify that each activity is being consistently carried out. EpilogueAfter running an errand with a boy I met at college, my grandfather happily reported back to me, “He didn’t roll through a single stop sign coming down Green Hill Road. He’s all right, that one.”My grandfather, a retired police detective for the city of Pittsburgh, knew how to read a person. That boy and I celebrated our 30th anniversary last month.I was a child bride.If you found this article helpful, you might also like:Anticipating Tensions Between Clinical Care and Study ProtocolAvoiding Protocol Deviations Full Article clinical research clinical trials PI Oversight pre-study site visit protocol amendments
gh FDA Puts Santa on the Naughty List! By polarisconsultants.blogspot.com Published On :: Sun, 09 Dec 2018 18:56:00 +0000 WARNING LETTERVIA UNITED PARCEL SERVICESIGNATURE REQUIREDDecember 1, 2018Mr. Kris Kringle, OwnerSanta’s Workshop, LLC1225 Santa Clause WayNorth Pole, Arctic Circle Dear Mr. Kringle:The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at1225 Santa Claus Way, North Pole Arctic Circle, from April 2 to April 20, 2018.This warning letter summarizes significant violations of CGMP regulations for finished product. See 21 CFR, parts 210 and 211. During our inspection, our investigators observed specific violations including, but not limited to, the following.CGMP Violations 1. Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a) and 211.28).Many members of your Enterprise Labor Force (ELF) unit lacked sufficient prior experience for designing and assembling (b)(4). At the time of our inspection, no ELF members had received training on CGMPs, and most were unaware of their responsibilities in the areas of cleanliness and proper attire. Hands and faces were often coated with chocolate, and bells on hats and shoes prevented protective apparel from attaining a proper fit. More generally, factory staff demonstrated an undisciplined, almost gleeful disregard for quality procedures. On three separate occasions, at critical stages of the manufacturing process, floor workers erupted into spontaneous song and dance.Your written response of May 18, 2018 is inadequate because it does not address these training and experience deficiencies. While endearing, the ability to “sit on a shelf” or “live in a hollow tree” does not constitute acceptable manufacturing experience. Candy coating does not qualify as protective covering. And sticking one’s hands in a nearby snowdrift is not a recognized sanitation procedure. “Pure as the driven snow” is not a thing. Especially with all those reindeer knocking about.2. Your firm failed to maintain a system by which the distribution of each lot of product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).Product distribution records were incomplete and, in the event of a recall, would be insufficient to identify all product recipients.Your written response of May 18, 2018 is inadequate. Santa’s Own Procedures (SOPs) are insufficient to capture the information required to conduct a thorough recall. Mr. Kringle may well know which customers are naughty and which are nice -- who’s good, who’s bad, who’s sleeping, and who’s awake, but this information is not written down and, in the opinion of our investigators, would be of limited value if it were. 3. Your firm failed to store product at an appropriate temperature to ensure the identity, strength, quality, and purity of the products are not affected (21 CFR 211.142(b)).Entire sections of the facility lacked effective air conditioning, resulting in destruction of all (b)(4) warehoused in two large storage rooms. A third inadequately cooled room was not in use, and except for some miscellaneous items – a couple hunks of coal, a corncob pipe, and a large, oddly sad puddle of water – the room was all but empty.Your written response of May 18, 2108 was inadequate. FDA isn’t really sure what to do with “that old silk hat we found” in your response package.4. Products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed (21 CFR 211.165(f)). While not strictly a violation of 21 CFR 211.165(f), the rejection and quarantining procedures your firm follows for products that fail to meet established criteria is concerning. While it’s appropriate to reject a (b)(4) that swims, a (b)(4) with square wheels, a (b)(4) that shoots jelly, and a (b)(4) that rides an ostrich, exile to a remote island ruled by a flying lion is, in a word, extreme. Your firm also rejected and exiled a (b)(4)-in-a-box for what was almost certainly an easily remediated labeling problem; reprocessing would have been a more appropriate course of action. Also, we just have to know. Seriously. WHAT WAS WRONG WITH THE DOLLY???5. Your firm failed to establish adequate acceptance criteria for sampling and testing necessary to assure that batches of product meet appropriate specifications as a condition of their approval and release (21 CFR 211.165(d)). Sampling procedures consisted of pulling each finished batch of (b)(4) out of a hot oven, taking a few nibbles, and declaring it “Jingle-icious.” Testers would frequently adulterate samples by submersing and saturating them with milk. These procedures are totally without scientific rigor. Furthermore, sampling was not restricted to members of the Quality Control Unit, but was extended to the entire plant floor. At times, sampling frequency was so high that there was very little, if any, of (b)(4) left to distribute. (On a personal note, our investigators would like to express their appreciation for the opportunity to participate in the testing activity. All the batches they sampled exceeded the strictest statistical quality control criteria, excepting the fruitcake, which could have benefited from additional stability testing and an earlier expiry date.)ConclusionViolations in this letter are not intended as an all-inclusive list. Typically the manufacturer is responsible for investigating violations, determining their root causes, and preventing their recurrence. However, in this case we’re going to make an exception. Though your methods and procedures are unconventional and frequently out of compliance with regulations, they are not wholly without merit. Our investigators have never experienced such a high level of workplace morale -- some calling it “downright merry” – and believe it warrants further observation. Investigators have suggested a series of mutually consultative visits to your workshop. Music, dance, batch samples, reindeer games, and the occasional adulterated eggnog are highly encouraged.Sincerely,/S/Holly BushDivision Director/OPQO Division INorth Pole District Office Full Article 21 CFR 211 CGMP GMP Santa FDA Inspection Santa GMP Inspection Santa Warning Letter
gh Sanofi at forefront of fight against COVID-19 in Q1 2020 By www.news.sanofi.us Published On :: Fri, 24 Apr 2020 07:00:00 -0400 Full Article
gh Phase 3 trial of Libtayo® (cemiplimab) as monotherapy for first-line advanced non-small cell lung cancer stopped early due to highly significant improvement in overall survival By www.news.sanofi.us Published On :: Mon, 27 Apr 2020 08:40:00 -0400 - Libtayo decreased the risk of death by 32.4% compared to chemotherapy Full Article
gh Is India right on its processes but wrong on its drug quality? By searchingforsafety.net Published On :: Tue, 14 Oct 2014 03:31:12 GMT Posted by Roger Bate India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to li [...] Full Article Uncategorized
gh Ebola is not the only health concern for Africans or Americans: how Egypt aims to improve its drug quality oversight By searchingforsafety.net Published On :: Thu, 30 Oct 2014 14:51:38 GMT Posted by Roger Bate Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad &ndash [...] Full Article Uncategorized
gh The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs By searchingforsafety.net Published On :: Mon, 16 Mar 2015 03:06:17 GMT Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. You can read the op-ed here [...] Full Article Uncategorized
gh The TSA Hoarded 1.3 Million N95 Masks Even Though Airports Are Empty and It Doesn’t Need Them By tracking.feedpress.it Published On :: 2020-05-06T13:05:00-04:00 by J. David McSwane ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Transportation Security Administration ignored guidance from the Department of Homeland Security and internal pushback from two agency officials when it stockpiled more than 1.3 million N95 respirator masks instead of donating them to hospitals, internal records and interviews show. Internal concerns were raised in early April, when COVID-19 cases were growing by the thousands and hospitals in some parts of the country were overrun and desperate for supplies. The agency held on to the cache of life-saving masks even as the number of people coming through U.S. airports dropped by 95% and the TSA instructed many employees to stay home to avoid being infected. Meanwhile, other federal agencies, including the Department of Veterans Affairs’ vast network of hospitals, scrounged for the personal protective equipment that doctors and nurses are dying without. “We don’t need them. People who are in an infectious environment need them. Nobody is flying,” Charles Kielkopf, a TSA attorney based in Columbus, Ohio, told ProPublica. “You don’t take things for yourself. It’s the wrong thing to do.” Kielkopf shared a copy of an official whistleblower complaint he filed Monday. In it, he alleges the agency had engaged in gross mismanagement that represented a “substantial and specific danger to public health.” TSA has not required its screeners to wear N95s, which require fitting and training to use properly, and internal memos show most are using surgical masks, which are more widely available but are less effective and lack the same filtering ability. Kielkopf raised a red flag last month about the TSA’s plan to store N95 respirators it had been given by Customs and Border Protection, which found more than a million old but usable masks in an Indiana warehouse. Both agencies are overseen by DHS. That shipment added to 116,000 N95s the TSA had left over from the swine flu pandemic of 2009, a TSA memo shows. While both stockpiles were older than the manufacturer’s recommended shelf life, the Centers for Disease Control and Prevention said that expired masks remain effective against spreading the virus. Kielkopf and another TSA official in Minnesota suggested that the agency send its N95 masks to hospitals in early April, records show. Instead, TSA quietly stored many of them in its warehouse near the Dallas-Fort Worth airport and dispersed the rest to empty airports across the nation. “We need to reserve medical masks for health care workers,” Kielkopf said, “not TSA workers who are behind an X-ray machine.” The Number of Travelers Passing TSA Checkpoints Has Dropped to Historic Lows Source: Transportation Security Administration The TSA didn’t provide answers to several detailed questions sent by ProPublica, but spokesman Mark Howell said in an email that the agency’s “highest priority is to ensure the health, safety and security of our workforce and the American people.” “With the support of CBP and DHS, in April, TSA was able to ensure a sufficient supply of N95 masks would be available for any officer who chose to wear one and completed the requisite training,” the statement read. “We are continuing to acquire additional personal protective equipment for our employees to ensure both their and the traveling public’s health and safety based on our current staffing needs, and as supplies become available,” TSA said. A review of federal contracting data shows the agency has mostly made modest purchases such as a $231,000 purchase for gallons of disinfectant, but has not reported any new purchases of N95s. An internal TSA memo last month said the surplus of N95s was expected to last the agency about 30 days, but the same memo noted that estimate did not account for the drastic decline in security officers working at airports. ProPublica asked how long the masks were actually going to last, accounting for the decreased staffing levels. “While we cannot provide details on staffing, passenger throughput and corresponding operations have certainly decreased,” the TSA statement said. The trade journal Government Executive reported this week that internal TSA records showed most employee schedules have been “sharply abbreviated,” while an additional 8,000 security screeners are on paid leave over concerns that they could be exposed to the virus. More than 500 TSA employees have tested positive for COVID-19, the agency reported, and five have died. The CDC has not recommended the use of N95s by TSA staff, records show, but that doesn’t mean workers who have or want to wear them can’t. In one April 7 email, DHS Deputy Under Secretary for Management Randolph D. Alles sent guidance to TSA officials, urging them to wear homemade cloth face coverings and maintain social distancing. But the N95s, which block 95% of particles that can transmit the virus, were in notoriously short supply and should be “reserved” for health care workers. “The CDC has given us very good information about how to make masks that are suitable, so that we can continue to reserve medical masks and PPE for healthcare workers battling the COVID-19 pandemic,” Alles wrote. But two days later, on April 9, Cliff Van Leuven, TSA’s federal security director in Minnesota, followed up and asked why he had been sent thousands of masks despite that guidance. “I just received 9,000 N-95 masks that I have very little to no need for,” he said in the email, which was first reported by Government Executive. “We’ve made N95s available to our staff and, of the officers who wear masks, they overwhelmingly prefer the surgical masks we just received after a couple months on back order.” Minnesota Gov. Tim Walz had publicly asked that anyone who had PPE donate their surplus to the state’s Department of Health, Van Leuven said in the email to senior TSA staff. “I’d like to donate the bulk of our current stock of N-95s in support of that need and keep a small supply on hand,” he wrote, adding the Minneapolis-St. Paul International Airport had screened fewer than 1,500 people the previous day, about a third of which were airport staff. Van Leuven declined to comment, referring questions to a TSA spokesperson. Later that day, Kielkopf forwarded the concerns to TSA attorneys in other field offices, trying to get some attention to the stockpile he felt would be better used at hospitals. “I am sharing with you some issues we are having with n95 masks in Minnesota,” he wrote. “And the tension between our increasing supply of n95 masks at our TSA airport locations and the dire need for them in the medical community.” Weeks went by, and finally, on May 1, Kielkopf wrote: “I have been very disappointed in our position to keep tens of thousands of n95 masks while healthcare workers who have a medical requirement for the masks — because of their contact with infected people — still go without.” DHS did not respond to ProPublica’s questions about why it transferred N95 masks to TSA despite a top official saying they should be reserved for healthcare workers. “So now the TSA position is that we desperately need these masks for the protection of our people,” Kielkopf said. “At the same time, most of our people aren’t even working. It’s a complete 180 that doesn’t make any sense.” Do you have access to information about federal contracts that should be public? Email david.mcswane@propublica.org. Here’s how to send tips and documents to ProPublica securely. Full Article
gh CSL Behring joins pandemic R&D fight with antibody work By www.fiercebiotech.com Published On :: Wed, 06 May 2020 09:38:11 +0000 Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19. Full Article
gh Fortress joins KRAS race through Columbia University deal By www.fiercebiotech.com Published On :: Fri, 08 May 2020 12:35:03 +0000 Fortress Biotech has licensed a treatment for KRAS-driven cancers from Columbia University. Sticking to its blueprint, Fortress has set up a new biotech, Oncogenuity, to advance the preclinical asset and work to generate more oligonucleotides from the underlying platform. Full Article
gh BENEO president: ‘We have seen higher and more volatile demand during the pandemic’ By www.foodnavigator-usa.com Published On :: Tue, 05 May 2020 02:05:00 +0100 From fewer containers and reduced shift work at harbors to delays in planned maintenance in factories, the coronavirus pandemic is impacting global supply chains in myriad ways. FoodNavigator-USA (FNU) caught up with Jon Peters (JP), president at Beneo, a leading supplier of chicory root fiber, rice ingredients, and the specialty low-GI carbs Isomalt and Palatinose, to find out more. Full Article Suppliers
gh Personalized Nutrition: New research highlights value society places on genetic testing By www.nutraingredients-usa.com Published On :: Thu, 07 May 2020 15:58:00 +0100 The results provide priceless information on ancestry and predispositions to various illnesses. Full Article Research
gh Google Says Most Of Its Employees Will Likely Work Remotely Through End of Year By www.npr.org Published On :: Fri, 08 May 2020 16:22:07 -0400 The tech giant announces it is extending its previous work-from-home plans for most of its staff and will begin reopening offices this summer. Full Article