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.

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.

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

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.

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
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
Hello Anonymous  You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible. Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion. Biocompatibility if used, is generating test [More]

From : Communities>>Regulatory Open Forum
Hello, I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation.  These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following.  I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, [More]

Guangping Gao, the head of the Horae Gene Therapy Center at the University of Massachusetts Medical School, will partner with Philadelphia-based Spark Therapeutics to figure out better ways to get disease-curing genes into cells. The collaboration, announced this morning, gives Spark (Nasdaq: ONCE) the option for an exclusive, world-wide license for any intellectual property to come out of it. No financial terms were disclosed. Earlier this year, Gao was featured in Newsweek magazine for seemingly…

• Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced “critical” group with Kevzara higher-dose versus placebo and discontinuing less advanced “severe” group

The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.

The facility will be the companyâs second facility in Carlsbad specifically for its BioReliance viral and gene therapy service.

AskBio acquires gene therapy biotech working on treatments for neurodegenerative disorders.

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 [...]

by Joaquin Sapien

New York Attorney General Letitia James is looking into allegations that a Queens adult care facility has failed to protect residents from the deadly coronavirus and misled families about its spread, according to two lawmakers who asked for the inquiry and a relative of a resident who spoke to an investigator with the attorney general’s office.

In a separate action Tuesday, three residents of the Queens Adult Care Center sued the facility in federal court over similar allegations.

Both developments were prompted largely by ProPublica’s recent coverage of the facility, which houses both frail elderly residents and those with mental health issues. On April 2, we reported that workers and residents at the home were becoming ill with the coronavirus as residents wandered in and out of the home without any personal protective equipment. Family members later told ProPublica the management said no residents were sick with the virus at the time.

On April 25, ProPublica published a story and a short film with the PBS series Frontline about the harrowing experience of Natasha Roland, who rescued her father in the middle of the night as he suffered coronavirus symptoms so severe he could barely breathe. Roland, in heart-wrenching detail, described how the management of the Queens Adult Care Center repeatedly assured her that her 82-year-old father, Willie Roland, was safe, even as the virus swept through the facility. She said workers were too scared to care for him, forcing his girlfriend, Annetta King-Simpson, to do so. King-Simpson later fell ill herself. Roland and King-Simpson are now suing the facility in federal court.

In an interview, Assemblywoman Catalina Cruz, whose district covers Corona, Elmhurst and Jackson Heights, said she was troubled by what ProPublica reported. She said she hoped the attorney general can determine whether the Queens Adult Care Center had broken any laws.

“It didn’t sit right with me. I thought something was off here. So I said let’s have the experts look at whether there was a crime or a civil violation,” she said. “Folks who live in this adult home deserve the same dignity as everyone else, and if their rights have been violated, someone needs to pay for that.”

Cruz said she had been suspicious of the facility for several years and had come across a community Facebook page where people posted complaints about treatment of residents at the center. When she saw the ProPublica stories, she said she decided to take action, along with City Council member Daniel Dromm, who had already written to the New York State Department of Health and the office of Gov. Andrew Cuomo about the spread of the coronavirus in the facility on several occasions.

“The plight of those living in adult care centers during this crisis was highlighted in a recent article published by ProPublica, which focused on the perils faced by the residents at the Queens Adult Day Care Center,” the lawmakers wrote in their April 27 letter to the attorney general and the governor’s office. “Failure to inform families about the health of loved ones, to lying and covering up deaths have become regular concerns we have received. We are aware that adult care centers are struggling to keep COVID-19 from affecting their residents and we also know that minorities have been disproportionately affected by the virus. It seems to us that management at this particular center have struggled to implement procedures and policies to protect the lives of its residents.”

Cruz said she received an update from the attorney general’s office on May 5, saying it was looking into the matter but would not provide specific details.

Days after the lawmakers sent the letter, Natasha Roland, 35, said she received a phone call from an investigator with the attorney general’s office. Roland said she recapped what she had previously told ProPublica: She began to worry about her father’s safety when nearby Elmhurst Hospital became a viral hot spot, but the management repeatedly told her there were no coronavirus cases in the facility. She said she only found out the truth weeks later when a worker she was friendly with advised her to come and pick up her father because the virus was raging through the facility and aides were becoming too scared to check on residents. In a subsequent interview, that worker denied telling Roland to pick up her dad.

A spokesperson for the attorney general would not confirm or deny a specific, active investigation into the Queens Adult Care Center, but said James has received hundreds of complaints related to COVID-19 inside nursing homes and adult care facilities across the state and is investigating many of them.

For its part, the Queens Adult Care Center has denied any wrongdoing and repeated its belief that Roland’s allegations are “baseless.”

“Sadly, select elected officials and ProPublica have been intentionally misled with baseless assertions and utter fabrications crafted by the daughter of one of our long-term residents,” said Hank Sheinkopf, a crisis communications spokesperson hired by the facility. “We have strong reason to believe that this individual is seeking to use her father and other select residents as pawns in an attempt to extort the facility. We are considering our legal options.”

He said the facility has “worked tirelessly” to protect its residents and is unaware of a “potential investigation,” but understood that “the AG’s office has contacted many nursing homes, adult care, and assisted living facilities seeking information. We are glad to be a resource to the AG’s office and have nothing to hide.”

Bruce Schoengood’s 61-year-old brother, Bryan, lives in the facility and shared a room with one of the first residents to become infected with COVID-19 and subsequently die of the disease. Bruce told ProPublica he only learned that his brother’s roommate had died by happenstance during a casual conversation with his brother, and that he has complained for more than a month about a lack of communication from the facility. He said he had not yet heard from anyone with the attorney general’s office but would welcome such a conversation.

In the meantime, Bryan Schoengood, Willie Roland and King-Simpson are suing the facility under the Americans with Disabilities Act. In a 59-page complaint, the group has asked a federal judge to appoint a special master to oversee the facility at the home’s expense to ensure that residents there are safe.

The lawsuit argues that residents have experienced a “gross failure to provide the most basic level of care to safeguard their health and safety in the context of a global health pandemic. People with disabilities are exposed to high risks of contracting the virus with no or few preventative measures in place. Residents who fall sick are left to languish in their room without proper access to medical care.”

The lawsuit claims that because the facility has failed to follow state and federal guidelines, “COVID-19 is rampant in the facility among residents and staff alike.”

Alan Fuchsberg is the Manhattan-based personal injury and civil rights attorney representing the three Queens Adult Care Center residents.

In an interview, he said that the facility may not have the resources to properly follow the guidelines, which is why a special master should be assigned to work with a team of outside experts to make sure it can.

“Right now the residents are in a tinderbox,” he said. “And if you drop a match in there, all hell breaks loose. It should be run right. We don’t need dozens of people dying in all our nursing homes and adult care facilities. Some are running better than others and QACC sounds like a place that is not run up to standards.”

He and Bruce Schoengood pointed out that they are not currently suing for damages, but rather to persuade a court to immediately intervene and offer support to the facility’s roughly 350 residents.

Schoengood said the goals of the lawsuit are twofold.

“I think it is both short term and long term,” he said. “Immediate intervention to put proper protocols in place to treat the sick and stop the spread of coronavirus and to communicate with family members. And in the long term I would like to see this facility much better prepared to handle another pandemic or a second wave.”

Responding to the charges in the lawsuit, Sheinkopf again said that “the allegations are baseless and utter fabrications. Queens Adult Care Center (QACC) continues to meet all state issued guidelines.”

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Temple University researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. They believe the discovery could be used to develop new treatments for both spinal cord and optic nerve injuries.

BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor.

Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration.

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

Despite President Trump's statements that the coronavirus was released from a laboratory in Wuhan, scientist say the evidence points to a natural origin.

The surgeon general's report is the first in 30 years to focus entirely on quitting tobacco.

The startup sources generic drugs directly from the manufacturer and sells it to retail pharmacies.

The post India: Ratan Tata picks up stake in pharma startup Generic Aadhaar appeared first on DealStreetAsia.