ht

Attorney General Holder Announces Justice Department Filings in Voting Rights Cases in Wisconsin and Ohio

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



  • OPA Press Releases

ht

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

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



  • OPA Press Releases

ht

Six Alleged Members of the Almighty Imperial Gangsters Nation Gang Indicted

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



  • OPA Press Releases

ht

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

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



  • OPA Press Releases

ht

Statement by Justice Department Spokesman on Latest Developments in Federal Civil Rights Investigation in Ferguson, Missouri

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



  • OPA Press Releases

ht

Attorney General Statement on Latest Developments in Federal Civil Rights Investigation in Ferguson, MO

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



  • OPA Press Releases

ht

Eight Alleged Members and Associates of the Two Six Nation Street Gang Indicted for Racketeering Conspiracy

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



  • OPA Press Releases

ht

Six Former Puerto Rico Police Officers Plead Guilty to Federal Civil Rights, Obstruction of Justice and Perjury Charges

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.



  • OPA Press Releases

ht

Justice Department Participates in Child Cyber Safety Night at Nationals Park, Saturday, September 6th

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.



  • OPA Press Releases

ht

Relmada Therapeutics (RLMD): Sending The Right Signals?

Shares of Relmada Therapeutics Inc. (RLMD) have gained 19 percent so far this year and trade around $37.




ht

Recent Weight Management Ingredient Research Reflects Emerging Trends

Emphasis on fat and protein intake, reduced carbohydrate intake and gut health for managing weight are trends affecting the global weight management category.




ht

DSM Insight Series: 1 in 4 Consumers Prepare, Consume Breakfast in Less Than 5 Minutes

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.




ht

New Study Highlights OptiMSM's Influence on Key Metabolic Reactions

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.




ht

A Thoughtful Innovation: HP Ingredients Launches Quantum IQ for Cognitive Health

The cognitive-boost market just received another potent supplement ingredient–Quantum IQ Polygonum minus extract, exclusively from HP Ingredients, Inc. (HPI).




ht

Sunlight exposure and its role in skin-gut axis

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.




ht

Active nutrition and immunity: Getting the right balance

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.




ht

Empower Women to Fight Corruption: Dr Wan Azizah

The impact of corruption is far-reaching and devastating, especially for women.




ht

RE: UV Light Sterilizers

From : Communities>>Regulatory Open Forum
Hi, 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]




ht

RE: UV Light Sterilizers

From : Communities>>Regulatory Open Forum
Good 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]




ht

Love at First "Site": Early Signs of Strong PI Oversight

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 Detail
Any 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 Compliance
During 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 Ask
After 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.

Epilogue
After 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 Protocol
Avoiding Protocol Deviations




ht

FDA Puts Santa on the Naughty List!



 
 
 
 
WARNING LETTER


VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

December 1, 2018

Mr. Kris Kringle, Owner
Santa’s Workshop, LLC
1225 Santa Clause Way
North Pole, Arctic Circle
 
Dear Mr. Kringle:

The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at
1225 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.)

Conclusion

Violations 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 Bush
Division Director/OPQO Division I
North Pole District Office



  • 21 CFR 211
  • CGMP
  • GMP
  • Santa FDA Inspection
  • Santa GMP Inspection
  • Santa Warning Letter

ht

Sanofi at forefront of fight against COVID-19 in Q1 2020




ht

Mycenax sells tocilizumab biosimilar to Richter

Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar.




ht

Is India right on its processes but wrong on its drug quality?

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 [...]




ht

Ebola is not the only health concern for Africans or Americans: how Egypt aims to improve its drug quality oversight

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 [...]




ht

The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs

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 [...]




ht

CSL Behring joins pandemic R&D fight with antibody work

Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19.




ht

Personalized Nutrition: New research highlights value society places on genetic testing

The results provide priceless information on ancestry and predispositions to various illnesses.




ht

Food for Thought (and Health): Day 2 Notes from the JP Morgan Healthcare Conference

Addressing the Social Determinants of Health:  Is the healthcare industry pushing a rock up a hill?  We collectively are trying to provide healthcare with improved quality and reduced cost, but the structure of the nation’s healthcare system remains heavily siloed with the social determinants of health often falling wholly or partly outside the mandate and...… Continue Reading




ht

MDR amendment proposal article 120 (3) oversight set to be fixed by Council

It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]




ht

I'm gaining weight in quarantine and I couldn't be more thrilled about it

If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude.




ht

The Check-In: Justin Turner unsettled at thought of not playing again for the Dodgers

The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter.




ht

'Every parent's nightmare': A child's death brings new coronavirus fears as more states reopen

The U.S. death toll in the coronavirus outbreak surpasses 77,000 as states continue to ease restrictions and President Trump pushes for faster reopening.




ht

Juul bought ad space on kids' websites, including Cartoon Network, lawsuit alleges

Over the past year Juul has faced criticism and scrutiny over its role in what public health officials call an "epidemic" of teen nicotine addiction.,




ht

Traditional Chinese cures battle for acceptance in COVID-19 fight




ht

Japan names 518 companies subject to tighter foreign ownership rules




ht

Kim Jong Un's sister and the fight for North Korea's bloodline




ht

Brightfield multiplex immunohistochemistry with multispectral imaging




ht

Immune dysfunction leads to mortality and organ injury in patients with COVID-19 in China: insights from ERS-COVID-19 study




ht

Correction to: A universal pipeline for mobile mRNA detection and insights into heterografting advantages under chilling stress




ht

Light: Science & Applications




ht

Genetic structure in hybrids and progenitors provides insight into processes underlying an invasive cattail (<i>Typha</i> × <i>glauca</i>) hybrid zone




ht

A stereotyped light chain may shape virus-specific B-cell receptors in HCV-dependent lymphoproliferative disorders




ht

Reconsidering marrow stem cell cycle status: insights into an actively cycling hematopoietic stem cell population




ht

Daily briefing: How desperate measures might shorten the coronavirus vaccine timeline — and at what risk




ht

Daily briefing: Closest black hole ever discovered was ‘hiding in plain sight’




ht

Statin drugs might boost healthy gut microbes




ht

Cyber-spinach turns sunlight into sugar




ht

Molecular profiling of stroma highlights stratifin as a novel biomarker of poor prognosis in pancreatic ductal adenocarcinoma




ht

How does spaceflight affect the acquired immune system?

npj Microgravity, Published online: 07 May 2020; doi:10.1038/s41526-020-0104-1

How does spaceflight affect the acquired immune system?