A former owner and operator of a Florida-based airline fuel supply service company pleaded guilty today to participating in a kickback scheme to defraud Illinois-based Ryan International Airlines, a charter airline company located in Rockford, Ill.

In testimony delivered before the U.S. Sentencing Commission Thursday, Attorney General Eric Holder endorsed a proposed change to the Federal Sentencing Guidelines that would reserve the harshest penalties for the most serious drug offenders.

Schools must support children as they learn expectations about behavior and conduct. But a routine school discipline infraction should land a student in a principal’s office – not in a police precinct.

The Department of Justice’s Antitrust Division today announced a new streamlined procedure that will lower the costs and expedite the review process for parties seeking to modify or terminate old antitrust settlements and litigated judgments.

As the April 15 tax filing deadline approaches, Attorney General Eric Holder warned U.S. tax filers to beware a “rising threat” of scammers seeking fraudulent refunds based on stolen identities, and vowed aggressive enforcement against the practice. Speaking in a recorded video message released on the Justice Department’s website, Attorney General Holder explained that a growing pool of criminals are engaged in the activity, including gangs and drug sellers seeking quick access to cash.

U.S. Attorney General Eric Holder—who testified before the U.S. Sentencing Commission last month in support of a proposal to reduce the federal sentencing guidelines for low-level, nonviolent drug offenders—released the following statement Thursday in response to the Commission voting to formally adopt those changes.

"We’re pleased that the court agreed that the department’s remedy will enhance system-wide competition in the airline industry," said Assistant Attorney General Baer

A Phoenix man convicted after a jury trial last December of conspiracy and racketeering offenses for his involvement in a sophisticated cybercrime organization was sentenced today to serve 20 years in prison.

A former owner and operator of a Florida-based airline fuel supply service company was sentenced today to serve 50 months in prison for participating in a scheme to defraud Illinois-based Ryan International Airlines.

“If an institution is unwilling to admit its wrongful conduct in a statement of facts; or balks at paying a substantial penalty that reflects that conduct; or refuses to do right by those affected, then we will not shrink from litigating as long as we must to fulfill our law enforcement mandate.”

ExxonMobil Pipeline Company (ExxonMobil) has agreed to pay a civil penalty for an alleged violation of the Clean Water Act stemming from a 2012 crude oil spill from ExxonMobil’s “North Line” pipeline near Torbert, Louisiana, the Department of Justice and the Environmental Protection Agency (EPA) announced today. Under the consent decree lodged today in federal court, ExxonMobil will pay $1,437,120 to resolve the government’s claim

Today the U.S. Department of Justice Office of Community Oriented Policing Services (COPS Office) released Implementing a Body-Worn Camera Program: Recommendations and Lessons Learned. The report analyzes some of the costs and benefits of law enforcement using body-worn video technology.

More than 56 million people in the United States live in areas with dentist shortages. Dental therapy is a proven solution that has helped increase access to care. Dental therapists are midlevel providers who deliver preventive and routine restorative treatment at schools, nursing homes, and veterans homes to people who would otherwise struggle to get access to care.

NutraIngredients is pleased to announce the shortlisted finalists for the 2020 edition of the NutraIngredients Awards ... with the winners to be announced in the first online awards ceremony next week (May 13th).

From : Communities>>Regulatory Open Forum
Great! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Hello, Does anyone know how long FDA's EUA process takes for approval compared to a 510k.  EUA seems to ask a lot of the same information that a 510k requests so not clear on what the benefits are or if it's worthwhile.  I assume you will eventually have to achieve traditional market clearance at some point. Any insight would be most appreciated. Thank you.

From : Communities>>Regulatory Open Forum
Hello,  I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website.  Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice?  Thanks Ankur RAC

From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]

From : Communities>>Regulatory Open Forum
These are all unapproved new drugs. Many people who have very limited knowledge of our OTC drug system, assume that if it is sold OTC, it is a monographed drug and they can change the formulation. They do not know that there are two types of OTC drugs allowed-compliance with a monograph or NDA. Minoxidil is one and chlorhexidine antiseptic wash is another. ------------------------------ David Steinberg,FRAPS President Steinberg & Associates, Inc. Pompton Plains NJ USA 609-902-8860 -------------- [More]

From : Communities>>Regulatory Open Forum
The only  possible way I can see any of these products being legally marketed in the US without going the OTC NDA route would be if the ingredients  other than Minoxidil are considered "inactive" and have some purpose (other than their active ingredient purposes) in the formulation.  That said, this might work for the last combination in your listing because all of these can and are often used in OTC products as inactive ingredients with understood and current reasons for existing in a formulation [More]

From : Communities>>Regulatory Open Forum
Hello, The EUA is much faster than the 510(k) process.  However, the EUA intended uses are only authorized during the state of emergency.  Once the state of emergency ends so does your authorization for the EUA intended uses.  The 510(k) clearance is permanent and authorizes the product with its cleared intended uses, to be put into interstate commerce. Hope that helps. ------------------------------ William Coulston PMP, MS, RAC Quality & Regulatory Manager San Antonio TX United States -------- [More]

From : Communities>>Regulatory Open Forum
Annie: Thank you for sharing this news.  I am curious whether the Board considers this a limited exception or a potential new normal option going forward? Scott ------------------------------ Scott Bishop Houston TX United States ------------------------------ ------------------------------------------- Original Message: Sent: 04-May-2020 08:50 From: Annie O'Brien Subject: New: Take the RAC Exams Online this Summer! The RAC board has been working hard to find solutions offering more flexibility [More]

From : Communities>>Regulatory Open Forum
Yes, you will need to achieve a 510(k) clearance after the emergency use has been officially ended by the FDA as William mentions.  Much of the information is the same, but the review process is intended to be expedited.  If you want to continue selling the product in the United States after the emergency use, you should really submit a 510(k) now; while the virus issue may continue for a few months it will take a few months for 510(k) clearance.  And if you have an EUA Approval this really is not [More]

From : Communities>>Regulatory Open Forum
These types of products and combinations you mention are all unapproved drugs and unapproved combinations.  Unless the specific combination is approved or listed in an OTC monograph, it is a new drug and requires a NDA to market it.  Minoxidil is a Rx to OTC switch product so it requires a NDA or ANDA to market this drug in the US, even as a OTC drug.  Thus any combination with minoxidil is a new drug. In the past the FDA has also specifically stated that combining different types of products (drug [More]

- Libtayo decreased the risk of death by 32.4% compared to chemotherapy

Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)

An online educational course has been published by Medscape in collaboration with the Association of Diabetes Care & Education Specialist.

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].

Takeda in global licensing agreement with ProThera to develop plasma-based therapies for inflammatory conditions.

Menarini adds Stemlineâs lead product, Elzonris, and its presence in the US with buyout deal.

Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. 

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April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade […]

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

Tough times at Orchard Therapeutics as it swings the ax across staffers and facilities, phases in new pipeline advances and reduces interest in others.

The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.

Yokogawa Electric Corporation (TOKYO: 6841) announces that Yokogawa Solution Service Corporation, a wholly owned subsidiary, has installed a Yokogawa control system for one of Japan's largest wind-power plants, and that this facility, Wind Farm Tsugaru, has come online. This plant was built by Green Power Tsugaru GK, a limited liability company that belongs to Green Power Investment Corporation.

Punjab Education Board Punjab Recruitment 2020 Online Application Last Date Extended at educationrecruitmentboard.com. Check details here.

Sarva Shiksha Abhiyan (SSA), Department of School Education Punjab, has published the recruitment notification for the post of Master/Mistress Cadre.

OSCB Recruitment 2020 Online Application for 786 is being filled up at rcsodisha.nic.in . Check details here.

RBI Recruitment 2020 Notification is out at rbi.org.in. Check details here.

The Trendlines Group has invested in early-stage startup Insectta, headquartered in the city-state.

The post SG Digest: Trendlines invests in Insectta; d:tribe Capital backs Australian AI startup appeared first on DealStreetAsia.

The VC firm manages four funds with about 2.5 billion yuan ($352 million) in total AUM.

The post Chinese VC Linear Capital reaches first close of latest USD fund at $110m appeared first on DealStreetAsia.