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

A greater Detroit-area owner of three home health agencies pleaded guilty today for his role in a $22 million home health care fraud scheme

“The eyes of the nation and the world are watching Ferguson right now. The world is watching because the issues raised by the shooting of Michael Brown predate this incident. This is something that has a history to it and the history simmers beneath the surface in more communities than just Ferguson."

We have brought to this area very experienced prosecutors, we have very experienced agents who are handling this matter, and doing so, I think, in a fine way. I'm going to get briefed on more of the details about the investigation. I've been kept up to date, but there's nothing that can replace actually coming to the office that's handling the matter, and being able to look in the face the people who are, I think at this point, very ably handling this investigation.

"We are here to announce a historic step forward in our ongoing effort to protect the American people from financial fraud – and to hold accountable those whose actions threatened the integrity of our financial markets and undermined the stability of our economy."

"Yet in addition to accountability, this historic resolution is also significant for what it achieves in terms of restoration: it requires those we are holding accountable to shoulder some of the responsibility for repairing the damage caused by their conduct."

Associate Attorney General Tony West today announced $3 million dollars in grants from the Office on Violence Against Women (OVW) to increase local and tribal capacity to prosecute crimes of violence against women and provide services to victims of sexual assault, domestic violence and stalking in the Bakken Region of North Dakota and Montana

Thank you, Carlie for that kind introduction and for hosting this important gathering along with U.S. Attorneys Judge Leonardo from the District of Arizona, John Walsh from the District of Colorado, and Damon Martinez from the District of New Mexico.

Attorney General Eric Holder released the following statement Wednesday on the departure, effective September 15, of Associate Attorney General Tony West:

Attorney General Eric Holder released the following statement Wednesday on the resignation of U.S. Attorney Jenny Durkan for the Western District of Washington:

A Colombian man extradited to the Eastern District of Virginia pleaded guilty today for his involvement in the kidnapping and murder of Drug Enforcement Administration (DEA) Special Agent James Terry Watson in Bogotá, Colombia, on June 20, 2013.

Attorney General Eric Holder announced today that the Justice Department has launched two initiatives to address concerns about police services in the city of Ferguson and in St. Louis County, Missouri.

"These anecdotal accounts underscored the history of mistrust of law enforcement in Ferguson that has received a good deal of attention. As a result of this history – and following an extensive review of documented allegations and other available data – we have determined that there is cause for the Justice Department to open an investigation to determine whether Ferguson Police officials have engaged in a pattern or practice of violations of the U.S. Constitution or federal law."

Attorney General Eric Holder released the following statement Friday announcing that Stuart Delery, who currently serves as Assistant Attorney General for the Civil Division, will serve as Acting Associate Attorney General, which is the Justice Department’s third-ranking post.

Calling prescription drug addiction an “urgent and growing threat” to our nation’s public health, Attorney General Eric Holder on Monday announced a new Drug Enforcement Administration(DEA) regulation that would allow pharmacies, hospitals, clinics, and other authorized collectors to serve as authorized drop-off sites for unused prescription drugs.

Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division today announced that Sung-Hee Suh has been appointed to serve as Deputy Assistant Attorney General overseeing the Appellate, Capital Case and Fraud Sections.

The following statement is attributable to Justice Department spokesman Brian Fallon regarding Attorney General Eric Holder’s visit to Mexico City today to meet with his fellow attorneys general from across Central America to discuss the situation involving migrant children.

Chairman Carper, Ranking Member Coburn and distinguished members of the committee, thank you for inviting me to speak with you today about the Department of Justice’s role in supporting state, local and tribal law enforcement agencies.

Thank you, Monty [Wilkinson], not only for your kind words – but also for your outstanding leadership of the Executive Office for United States Attorneys.

"At every level, Tony West has come to exemplify what it means to be a public servant in the truest sense. To many who are at risk and in need, he has become known as a champion. To those who have broken the law and victimized others, he has been a fierce and determined guardian of the public trust. And to me, he has been a trusted advisor, a dedicated colleague, and a dear friend."

"I love this department because of its unique mission. It's an audacious one -- I suppose with a name like “Justice” audacity is appropriate. It's a mission that speaks to the fundamental importance of the Rule of Law, as represented by that statue on your far right, aptly named the “Majesty of Law,” a bundle of arrows in hand."

Attorney General Eric Holder released the following statement Thursday announcing Joyce Branda as Acting Assistant Attorney General for the Civil Division.

On January 15, 2009, the U.S. Foreign Intelligence Surveillance Court of Review (FISC-R) published an unclassified version of its opinion in In Re: Directives Pursuant to Section 105B of the Foreign Intelligence Surveillance Act, 551 F.3d 1004 (Foreign Intel. Surv. Ct. Rev. 2008). The classified version of the opinion was issued on August 22, 2008, following a challenge by Yahoo! Inc. (Yahoo!) to directives issued under the Protect America Act of 2007 (PAA). Today, following a renewed declassification review, the Executive Branch is publicly releasing various documents from this litigation, including legal briefs and additional sections of the 2008 FISC-R opinion, with appropriate redactions to protect national security information. These documents are available at the website of the Office of the Director of National Intelligence (ODNI), www.dni.gov; and ODNI’s public website dedicated to fostering greater public visibility into the intelligence activities of the U.S. Government, IContheRecord.tumblr.com. A summary of the underlying litigation follows.

Buenas tardes. Muchas gracias por sus emotivas palabras y su calurosa bienvenida. It’s a privilege to help welcome the Hispanic National Bar Association to our nation’s capital for your 39th Annual Convention. And it’s a great pleasure, as always, to be in such distinguished company.

Attorney General Eric Holder announced Monday that the Justice Department will launch a new series of pilot programs in cities across the country to bring together community representatives, public safety officials and religious leaders to counter violent extremism. The new programs will be run in partnership with the White House, the Department of Homeland Security, and the National Counterterrorism Center.

The Justice Department announced Monday that Attorney General Eric Holder has recorded a video message as part of the Cartoon Network’s “I Speak Up” campaign to combat bullying. The project urges young people to speak up in order to help bring bullying situations to an end.

Thank you, John, not only for that kind introduction but also for your exemplary leadership as chair of the LSC Board. LSC really exemplifies that spirit Attorney General Robert Kennedy used to talk about – that as lawyers, we have an obligation to enlist our skills and ourselves in engagements that reach beyond the horizons of our parochial legal practices. And over the last five-and-a-half years I’ve served in this Administration, I’ve been fortunate to get to know John and LSC President Jim Sandman, and I know the movement for expanding access to justice in this country is better and stronger because they’re helping to lead this effort, so my thanks to them.

Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division has signed an antitrust cooperation agreement with the Colombian antitrust agency on behalf of the Department of Justice. The agreement also was signed by Federal Trade Commission Chairwoman Edith Ramirez, and went into effect today with the signature of Pablo Felipe Robledo, Colombia’s Superintendent of Industry and Commerce.

Attorney General Eric Holder is set to announce a partnership between the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the Department of Housing and Urban Development (HUD). HUD will offer new grants to support collaborations between HUD-funded organizations, and civil legal aid programs and public defender offices. The grant funded collaborations will focus on expunging and sealing juvenile records – improving the chances that reentering youth will be able to obtain degrees, find work and secure housing. The announcement is set to be made this evening during the Attorney General’s remarks to the Legal Services Corporation 40th anniversary celebration.

Thank you, Dean [Martha] Minow, for those kind words – and thank you all for being here. I also want to recognize, and thank, my good friends John Levi and Jim Sandman for their leadership of the Legal Services Corporation over the years – and for the lifetimes of tireless work that they have dedicated to vulnerable populations from coast to coast. Finally, I want to thank each and every one of you – the dedicated men and women who are making LSC’s work possible; who are helping to shine a light on the current challenges facing the legal aid community; and who are leading us to redouble our efforts to forge the more just society that all Americans deserve. It’s gratifying to see so many diverse people and interests – from academia and government service, to private practice and corporate enterprise – converging to support equal justice under law.

Qui tam cases are a vital part of the Criminal Division’s future efforts. We encourage you to reach out to criminal authorities in appropriate cases, even when you are discussing the case with civil authorities. The sooner we on the criminal side learn about potential criminal conduct, the sooner we can investigate.

A true cooperator – whether a mobster or a company – must forthrightly provide all the available facts and evidence so that the most culpable individuals can be prosecuted. If a corporation wants credit for cooperation, it must engage in comprehensive and timely cooperation; lip service simply will not do. Corporations do not act criminally, but for the actions of individuals. The Criminal Division intends to prosecute those individuals, whether they’re sitting on a sales desk or in a corporate suite.

Thank you, Professor [Jennifer] Arlen, for those kind words – and thank you all for being here. It’s a privilege to be at New York University this afternoon

Remarks as prepared for delivery

Thank you, Professor [Jennifer] Arlen, for that kind introduction and for everything you and your colleagues have accomplished at NYU

Remarks as prepared for delivery

Thank you, Buddy [Wilmer Parker], for that kind introduction

ALEXANDRIA, Va

NEWPORT NEWS, Va

The U.S. Food and Drug Administration approved a new high-pressure ventilator developed by NASA to treat coronavirus or COVID-19 patients. The space agency is offering the designs for licensing on a royalty-free basis during the time of the pandemic, hoping to increase the availability of life-saving medical devices.

The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

This blog post was written by Deanna Petersen, CBO of AVROBIO, as part of the From The Trenches feature of LifeSciVC. When AVROBIO went public in June 2018, I found myself on the steep end of an unexpected but interesting

The post Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective appeared first on LifeSciVC.

ChromaDex Corp. announced NIAGEN® nicotinamide riboside prevented neurological damage and improved cognitive and physical function in a new mouse model of Alzheimer’s disease.

An advertising agency agreed to settle a complaint brought by state and federal regulators over the creation and dissemination of allegedly deceptive radio advertisements for weight-loss products.

Rousselot, the collagen-based ingredients producer, has revealed a new study which it says provides important answers surrounding the bioavailability of collagen peptides and the modifications they undergo during digestion.

We need it for inclusive policymaking

Media registration is open for the APEC Concluding Senior Officials’ Meeting to take place on 7 December 2019 at the APEC Secretariat in Singapore.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304-  ANSI AAMI IEC   62304:2006/A1:2016 62366-1:2015-  Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More]

From : Communities>>Regulatory Open Forum
I disagree with Richard. I just had a conversation with the COVID-19 hotline (11:45 am, May 7) and asked about this issue after having read an update from the FDA that said UDIs for EUA devices are waived and GMPs are under limited enforcement. The person I spoke with said the update is correct and that UDIs are waived for EUA devices.  Feel free to contact me if you have any questions.  Bob Bard ------------------------------ Robert Bard JD, RAC [Managing Director] South Lyon MI United States - [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material. Here was a nice thread discussing the topic [More]

From : Communities>>Regulatory Open Forum
Bob, I stand corrected; if you confirmed with FDA that is good.  From what I was reading and seeing (I must have missed that update) there was nothing addressing UDI or no UDI.for EUA products.  (Personally I am a bit surprised at this since the whole concept of UDI is traceability and they waive this for emergency use products - when there is an issue this is where UDI becomes so important.  Shrugs.) ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs --- [More]

From : Communities>>Regulatory Open Forum
Hello Richard, Yesterday, I received a follow up from the Hotline (CDRH-EUA-Templates ) to my query. I was reminded that the waiver to good manufacturing practice and labeling requirements were included in the individual authorization letter. The person responding to my question concerning the UDI requirement provided the following: UDI is not specifically noted; however we are not enforcing UDI during the emergency. The specific authorization letter I was reviewing was for [More]