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.

The Justice Department today filed a lawsuit against the Kent State University, the Kent State University Board of Trustees and university officials for violating the Fair Housing Act by discriminating against students with disabilities in student housing.

Earlier today, Associate Attorney General Tony West, Assistant Attorney General Stuart Delery for the Civil Division and members of the Department’s Elder Justice Initiative met with stakeholders in the field of elder abuse and financial exploitation to launch the Elder Justice website.

The Department of Justice announced today that it has entered into a settlement agreement with the School District of Philadelphia that resolves a religious accommodations lawsuit filed in March 2014. In its lawsuit, the United States alleged that the school district violated Title VII of the Civil Rights Act of 1964 (Title VII) by failing to accommodate the religious beliefs, observances and/or practices of Siddiq Abu-Bakr, a school police officer who is Muslim, and similarly-situated employees who maintain a beard longer than one-quarter inch for religious purposes.

The United States has requested that the U.S. District Court for the Northern District of Mississippi permanently bar Nathaniel Kimble, Greenville, Mississippi, man from preparing federal income tax returns for others, the Justice Department announced today.

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

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.

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.

The Department of Justice and the Corporation for National and Community Service (CNCS), which administers AmeriCorps national service programs, has awarded $1.8 million in grants to increase the effective and efficient adjudication of immigration proceedings involving certain children who have crossed the U.S. border without a parent or legal guardian.

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.

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.

Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice.

Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.

The Justice Department announced today that under its settlements with five of the nation’s largest mortgage servicers, 952 service members and their co-borrowers are eligible to receive over $123 million for non-judicial foreclosures that violated the Servicemembers Civil Relief Act (SCRA)

The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses

ALEXANDRIA, Va

ALEXANDRIA, Va

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

Continue reading »

Ocean Spray Cranberries, Inc. is recalling Pink Lite Cranberry Juice Drink citing potential for undeclared sulfites, the U.S. Food and Drug Administration said in a statement. The recall involves a single production lot of 5.5oz cans of the drink with lot number MH0030LPK4 and Best Before Date of 24JAN21. The product is sold in boxes containing six 5.5oz cans. They were distributed to retail

The U.S. Food and Drug Administration granted marketing authorization to Medtronic Inc.'s CARPEDIEM System, a new device for continuous dialysis therapy for use in pediatric patients with certain kidney conditions. The system is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms.

The coronavirus pandemic has infected more than 2.5 million people worldwide, with the United States accounting for nearly 1 million of those cases.

Obese mice with unhealthy lifestyles gain significantly less weight and avoid type 2 diabetes when they receive bacteriophages from the faeces of a lean mouse, according to a new University of Copenhagen study.

The winner of the APEC Photo Contest 2019 has also won the most votes for the Popular Choice Award, announced the APEC Secretariat.

From : Communities>>Regulatory Open Forum
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]

From : Communities>>Regulatory Open Forum
Thank you Dinar! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
Thank you Richard! ------------------------------ MARIA GUDIEL Brea CA United States ------------------------------

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences?

From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]

Sangamo plans to utilize Mogrifyâs cell conversion technology to develop CAR-Treg cell therapies.

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

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading →

Posted by Roger Bate A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations. Compulsory licensing (CL) allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported. In some cases the price cuts of CL can be substantial, notably in Thailand, where key medicines dropped to about 10% of the original price. But researchers (in [...]

by Adriana Gallardo, ProPublica, and Ariel Goodman for ProPublica

They’ve gotten to know New York City in a way many have not, through the low-wage work of cleaning its skyscrapers, serving its restaurants and crisscrossing its streets on bicycles, through long subway rides very early in the morning and very late at night. The saying goes: You’re not a true New Yorker unless you’ve lived here for a decade. They’ve done their time and felt a deep sense of belonging in this city of immigrants.

But, in the epicenter of a pandemic, the undocumented have never felt more alone.

They are losing loved ones but do not qualify for city funding to help bury them. They are getting sick but hesitating to get tested or go to the hospital, balancing their fear of the virus with their fear of exposure to immigration authorities. They are worried about supporting their families abroad as well as those who live with them, weighing whether to keep working perilous jobs or to stay home and somehow keep food on the table.

They’ve experienced separation, but not like this — out in the world, in a skeleton crew, wearing a mask to deliver food to closed doors; in cramped apartments, sectioned off, in an attempt to quarantine. They are divided across national borders as family members die, praying novenas on Google Hangouts. Their bodies cannot be buried, intact, where they were born; they move from hospital bed, to refrigerated truck, to incinerator.

ProPublica interviewed two dozen undocumented Latino immigrants and their families about their experiences with death, illness and survival. Some spoke on the condition of anonymity, afraid of being targeted. Others allowed us to use their first names or the full names of their family members who died.

One kitchen worker from the Bronx worked in the World Trade Center two decades ago. “We used to fill the back elevators of those towers,” he said. He lost friends on Sept. 11, 2001, who were not identified or acknowledged among the dead because their names did not match those on record or their families were unable to claim the bodies.

He and others spoke to ProPublica because this time they wanted their experiences to be counted as part of the story of their city, overtaken by a virus.

Barriers to a Proper Burial

Adrian Hernandez Lopez, 38, never planned to stay in New York City. His 15 year stint here was dotted with visits to his family in Mexico, for the baptism of his son, who is now almost a teen, and to check on the house he had been sending his paychecks to build.

He and brother worked at an Italian restaurant in Times Square. “We were always together,” his brother said. They crossed the border together and, years later, commuted together from Queens to midtown Manhattan.

The last time they spoke by phone, Lopez waited in agony in a hard chair at Elmhurst Hospital, breathing in oxygen from a machine. He was transferred to Woodhull Hospital in Brooklyn. One day later, the father of two wound up in a vegetative state.

He died on April 2. His mother, who lives in Allende, a small village in the state of Puebla, wants him buried there, alongside two babies she lost just after birth.

He can’t be traditionally buried, despite the strong Mexican custom. More than 400 Mexican migrants are known to have died of COVID-19 in the New York area, but for health reasons, Mexico will only accept their bodies if they are cremated.

In place of seeing the body one last time, Lopez’s brother was sent photos by the funeral home, which will hold the cremains while the family figures out how to get them to Mexico.

The Mexican Consulate pledged financial aid to the families of nationals who died of COVID-19 complications, but it has been slow to materialize. According to Lopez’s brother, they’ve been asked to follow guidelines to receive a reimbursement. The Consulate General’s office in New York said it was not authorized by the Mexican government to give interviews at the time of our request for comment.

The city of New York provides burial assistance, but it requires a Social Security number for both the deceased and the person requesting funds. City officials say they are limited by federal and state law in the help they can offer. “We are exploring every possible option to ensure that all New Yorkers, regardless of immigration status, are able to bury their loved ones in the way they feel is most fitting,” city spokesperson Avery Cohen said.

Two members of the City Council have called for an emergency fund to provide assistance to all low-income families, including the undocumented.

“One of the most devastating calls I’m regularly getting is from people who can’t afford to bury their loved ones and aren’t eligible for any assistance,” Council Member Francisco Moya said in a release. “That’s simply not acceptable.”

Lopez’s family is one of several raising money for the transport and burial of their loved one who died in the United States.

As he tries to figure out how to send Lopez home, his brother sits in the small apartment they shared in Queens, with his wife and 6-year-old daughter, listening to the sirens that have become a constant reminder of their loss. He and his wife have been out of work for a month. They don’t know how they will pay the rent.

Deterred From Seeking Care

More than a dozen undocumented people told ProPublica that when they got sick, they stayed home, deterred from seeking care by the worry that they would not get it if they tried. They faced the same obstacles as everyone else in New York, where hospitals were crowded and unsafe, and feared additional ones involving their immigration status.

Fani lives in East Harlem. Over the last 18 years, she’s worked at a laundromat and a factory, a restaurant and as a babysitter. When she and her husband got sick they called 311. She said the voice on the other end confirmed their COVID-19 symptoms and told them to stay home unless they couldn’t breathe.

“They said there were no beds, no respirators. We healed each other as best we could with soups, teas and Tylenol,” she said.

Sonia, who became ill with COVID-19 symptoms almost three weeks ago, was afraid to go to the hospital. “I knew several people who went into the hospital with symptoms and they never came back,” she said. “That was my fear and why I decided to not go in. I preferred to isolate myself at home, with a lot of home remedies and hot teas.”

Multiple people said they knew hospitals had limited resources and worried they would be placed last in line for care because they were undocumented. “They’re going to let us die,” one man told his brother. A woman named Yogi in the Bronx said, “It might not be that they don’t want to treat us, maybe there weren’t enough supplies.”

Stories rippled through the Latino community about those who had difficulty getting care and those who could not be saved. According to a recent poll of voters in New York City, more than half of Latinos there said they know someone who died, the highest percentage of any group asked.

They hear stories about people like Juan Leonardo Torres, a 65-year-old retired doorman who knew someone on every corner of Corona, Queens. Unlike the others, Torres, from the Dominican Republic, was a citizen. Even so, he grew discouraged when he tried to get care.

Within one week at the end of March, Torres had gone from feeling slightly ill to experiencing difficulty breathing and fevers that his wife Mindy tried to manage using herbs and other “remedios caseros,” or home remedies. She and her five sons who lived with them finally persuaded him to go to Long Island Jewish Medical Center Forest Hills, just a five-minute drive from the house.

When Torres arrived, he told his family there were not enough seats in the crowded emergency room. He gave his chair up to an older woman and stood for hours as staff connected and disconnected him to an oxygen tank.

Fifteen hours later, on a drizzly night, Torres appeared at the door of the family home. It was 2:30 a.m. He had made the walk alone and declared in Spanish, “For no reason do I want to go to the hospital to die like a dog.”

He spent the next three days quarantined in his son’s room, where he died.

As the family waited six hours for his body to be retrieved, his wife sat in the living room “like a statue.”

Calculating Survival

Unable to qualify for relief programs like unemployment and stimulus cash, undocumented people are faced with the difficult choice of working dangerous jobs or running out of the money they need for essentials like food and housing.

“The little we have goes to food,” said Berenice, who suffers from kidney problems and whose son struggles with asthma. She’s been home for weeks along with her husband Luis, who before the pandemic worked at a cab company.

“Yes, we need money, but there is also our health,” Berenice said. “We have family who are sick and friends who died. We are trying to survive.”

Luis has lived in New York for 18 years, working his way up from delivering pizza on a bicycle to owning a cab. He worries about exposing his wife and son. “I just want this to pass and we’ll see about starting over again,” he said.

Adan lives in the Bronx with his two teenage sons, who were born in New York City, and his wife. She cleaned homes. He worked in a restaurant in East Harlem. Neither are working and both overcame COVID-19. “The little money we had went to pay last month’s rent,” he said. “I don’t know what to do, we just want to work.”

He said his landlord always comes looking for the rent in person. He told “el señor” that he’s spending all his money on food. The man gave him flyers about unemployment, but Adan knows he won’t qualify. “Me las voy a ver duras,” he said. He’s going to see hard times. He said he has lived in the same building for 11 years and has never missed a payment. Even though he can’t be evicted now, he said, “the debt will be there.”

Adding to the pressure, for some, is that they also work to support family members in their home countries, who count on the money they send.

One delivery worker in Queens sends $400 to Mexico every two weeks to help his son, who studies biomedicine at a university in Puebla; that helps him cover what he needs for school, including rent and transportation. He sends another $300 each month to his elderly mother.

He said he remains one of only a few bicycle delivery workers at his diner who are still on the job, and he is seeing more orders than usual. He’s always worked six days a week, but this past month was so busy, he couldn’t stop to eat lunch or take breaks.

He would much rather be outside than at home, but the streets feel tense. “I feel strange not seeing anyone or saying hi anymore, but I think it’s much better this way,” he said. “I understand why people are afraid.”

Even though he doesn’t see them in the buildings he visits, customers have been conscious about leaving tips in envelopes. He feels grateful as he passes the long lines in Queens of those waiting for free food. It makes him sad to know how many need it now.

He rents a room in an apartment he shares with three other men who have all lost their jobs. One was in construction, the other two in restaurants. He takes precautions to keep them safe when he comes home, including changing his clothes before coming in. “It would be irresponsible not to,” he said.

He hopes the rules of social distancing, and his mask and gloves, will protect him. “I’m not scared,” he said. “If you are afraid all the time, you will get sick faster.”

---

by ProPublica

The Pulitzer Board announced Monday that two series published by ProPublica were awarded Pulitzer Prizes. “Lawless,” a ProPublica Local Reporting Network project by the Anchorage Daily News that revealed how indigenous people in Alaska are denied public safety services, was awarded the prize for public service. “Disaster in the Pacific,” an investigation on the staggering leadership failures that led to deadly accidents in the Navy and Marines, won a national reporting prize. The two designations are ProPublica’s 6th Pulitzer win in 12 years and the first Pulitzer awarded to a Local Reporting Network partner.

Led by Daily News reporter Kyle Hopkins, “Lawless” was the first comprehensive investigation to lay bare Alaska’s failing, two-tiered justice system in which Native villages are denied access to first responders. In much of rural Alaska, villages can only be reached by plane, and calling 911 to report an emergency often means waiting hours or days for help to arrive.

The series evolved from a string of stories that Hopkins reported in 2018 for the Daily News, recounting horrific incidents of sexual assault in Alaska — which has the nation’s highest rate of sexual violence — and policing failures that have allowed offenders to continue the abuse with impunity. To fully investigate issues of lawlessness and sexual assault in the most remote communities in the U.S., the Daily News applied to participate in ProPublica’s Local Reporting Network. The program partners with newsrooms across the country, paying the salary and a stipend for benefits for local reporters who spend a year tackling big investigative stories that are crucial to their communities. Participating reporters work with a ProPublica senior editor and receive support, including from ProPublica’s data, research and engagement teams.

The collaboration’s first story, based on more than 750 public records requests and interviews, found that one in three rural Alaska communities has no local law enforcement of any kind. These indigenous communities are also among the country’s most vulnerable, with the highest rates of sexual assault, suicide and domestic violence. The series’ second major installment found that dozens of Alaska communities, desperate for police of any kind, hired officers convicted of felonies, domestic violence, assault and other offenses that would make them ineligible to work in law enforcement or even as security guards anywhere else in the country.

Next, Hopkins revealed how the state’s 40-year-old Village Public Safety Officer Program, designed to recruit villagers to work as life-saving first responders, has failed by every measure. Alaska had quietly denied funding for basic recruitment and equipment costs for these unarmed village officers while publicly claiming to prioritize public safety spending. “Lawless” also exposed how the Alaska State Troopers agency, created to protect Alaska Native villages, instead patrols mostly white suburbs surrounding cities on the road system like Wasilla. The series ended with a list of six practical solutions to Alaska’s law enforcement crisis, based on interviews with experts, village leaders, the Alaska congressional delegation and sexual assault survivors.

The Daily News and ProPublica faced a number of challenges in reporting the series. The first: No one knew which remote Alaska villages had police officers of any kind. So they built the first-ever statewide policing database by drawing on payroll, arrest and hiring records from communities spread across the state. They also contacted every village city government, sovereign tribal administrator and Alaska Native corporation in the state — more than 600 organizations.

The vastness of the state and the fact that 80% of communities aren’t on the road system posed another challenge. Journalists flew hundreds of miles, sleeping on the floors of schoolhouse libraries and riding in sleds and on snowmobiles. To aid the reporting, they also held a community meeting in Kotzebue, Alaska, where a 10-year-old girl had been raped and murdered in 2018, providing residents, advocates, tribal leaders and law enforcement their first chance for a public discussion on sexual violence. Throughout the year the reporters spoke to more than 300 people across the state.

Following publication of the first major story, U.S. Attorney General William Barr visited the state and declared the lack of law enforcement in rural Alaska to be a federal emergency. The declaration led the Department of Justice to promise more than $52 million in federal funding for public safety in Alaska villages. The U.S. Attorney’s Office in Anchorage announced the hiring of additional rural prosecutors, while Gov. Mike Dunleavy said the state will post 15 additional state troopers in rural Alaska. In addition, the Alaska Police Standards Council has proposed changing state regulations that govern the hiring and screening of village police officers, and Alaska legislators proposed legislation that would increase pay for VPSOs and overhaul funding of the program.

The Daily News’ Loren Holmes, Bill Roth, Marc Lester, David Hulen, Anne Raup, Vicky Ho, Alex Demarban, Jeff Parrott, Michelle Theriault Boots, Tess Williams, Tegan Hanlon, Zaz Hollander, Annie Zak, Shady Grove Oliver and Kevin Powell, as well as ProPublica’s Charles Ornstein, Adriana Gallardo, Alex Mierjeski, Beena Raghavendran, Nadia Sussman, Lylla Younes, Agnel Philip, Setareh Baig and David Sleight also contributed to the series.

“The ProPublica Local Reporting Network was started to give local newsrooms across America the resources and support they need to execute investigative journalism that digs deep and holds power to account,” Ornstein, a ProPublica deputy managing editor, said. “This powerful collaboration with the Anchorage Daily News investigation does exactly that, going far beyond reporting on isolated incidents to provide meticulous research and context on how the justice system has failed Alaska’s most remote and vulnerable communities. Most importantly, it has been a force for real change.”

In their “Disaster in the Pacific” series, ProPublica reporters T. Christian Miller, Megan Rose and Robert Faturechi centered on three deadly accidents in the Navy and Marines in 2017 and 2018. They exposed America’s vaunted 7th Fleet as being in crisis with broken ships and planes, poor training for and multiple warnings ignored by its commanders. The costs: 17 dead sailors in crashes involving Navy warships, and six Marines killed in a training accident.

The back-to-back accidents in 2017 and 2018 gained initial attention from Congress and the national media, but they had been told an incomplete, misleading and dangerous story of half-truths and cover-ups. ProPublica’s series provided the first full accounting of culpability, tracing responsibility to the highest uniformed and civilian ranks of the Navy. The reporting team spent 18 months on the investigation, obtaining more than 13,000 pages of confidential Navy records and interviewing hundreds of officials up and down the chain-of-command.

The first article in the series, “Fight the Ship,” reconstructed a 2017 crash involving the USS Fitzgerald, one of the deadliest accidents in the history of the Navy. The story showed that the accident was entirely preventable, and that the Navy’s senior leadership had endangered the warship by sending a shorthanded and undertrained crew to sea with outdated and poorly maintained equipment. To show readers what happened, ProPublica hired designer Xaquín G.V. Working with investigations producer Lucas Waldron, Xaquín used geodata on the ships’ locations, mapped the path of each vessel and created a graphic that simulated the crash, down to the moment the Fitzgerald was sent spinning out of control, rotating 360 degrees. The team also collected radar images, ship blueprints, hand-drawn images made by surviving sailors and video taken inside the ship, which allowed them to portray the disaster from the perspective of the sailors onboard.

A second story, “Years of Warnings, Then Death and Disaster,” detailed how the fatal crash of the USS Fitzgerald, and of the USS McCain weeks later, were the result of a congressional gutting of the Navy and the Navy’s prioritization of building new ships. Top Navy officials gave urgent, repeated warnings to Navy Secretary Ray Mabus about the deadly risks facing its fleet, including being short of sailors, sailors poorly trained and worked to exhaustion, warships physically coming apart, and ships routinely failing tests to see if they were prepared to handle warfighting duties. They were ignored, told to be quiet or even ordered to resign.

Another story captured the Marine Corps multiple failures that were responsible for the deaths of six men in a nighttime training exercise 15,000 feet above the Pacific — an accident that senior leaders had been warned was possible, even likely. ProPublica created an animated short documentary, using a combination of an on-camera interview, 3D animation, 2D illustration and atmospheric footage to bring the excruciating hours of a needless tragedy to light. Through extensive interviews with eyewitnesses, the team reconstructed the moments leading up to the crash, the crash itself and the botched search and rescue effort.

The series also illuminated how the Navy’s reckless management of the 7th Fleet was measured not only in fatalities, but also in the hurt and shame of the rank-and-file sailors whom the Navy blamed and prosecuted for the accidents. The Navy’s prosecution of Navy Cmdr. Bryce Benson for what were clearly systemic shortcomings, traceable all the way to the Pentagon, left many of its own furious and demoralized.

Weeks after the first story’s publication, the House Armed Services Committee convened a panel to challenge senior Navy leaders over their claims that they had been fully truthful about its failings and its efforts at reform. The reporting forced the Navy to admit to Congress that its claims about its rate of progress on reform were misleading. In light of ProPublica’s reporting on the improper role that the Navy’s top commander played in the prosecution of Benson, one of captains on the USS Fitzgerald, the Navy dropped all criminal charges. U.S. and NATO Navy commands throughout the world have ordered sailors and officers to read the ProPublica accounts as part of training and education.

Joseph Sexton, Tracy Weber, Agnes Chang, Katie Campbell, Joe Singer, Kengo Tsutsumi, Ruth Baron, David Sleight, Sisi Wei, Claire Perlman, Joshua Hunt and Nate Schweber also contributed to this series.

“The Navy actively blocked reporting at every step, with communications officers attempting to dissuade officials from conducting interviews with ProPublica and leaking positive stories to competing media outlets in an attempt to front-run our stories,” ProPublica Managing Editor Robin Fields said. “The military even threatened that we could be criminally prosecuted for publishing the material we obtained. This tour de force of investigative journalism is a testament to the unflinching tenacity of the reporters and the innovation of ProPublica’s data, graphics, research and design teams. Their essential work laid bare the avoidance of responsibility by the military’s most senior leaders.”

PhillyCooke Consulting has added new services from the humble start more than five years ago, when I used to joke that the company included both me and my laptop.

In addition to continuing to provide regulatory consulting services, PhillyCooke Consulting now offers:

• Submission Preparation Services for Ad Agencies
• Medical Editing
• Proofreading, and 
• Medical Writing. 

You can learn a bit more about the expanded services here, or simply complete the "Contact Form" to request a free initial consultation.

Also, having completed law school (and been admitted to the bar in Pennsylvania), I am now able to offer legal services; however, the law practice is distinct from PhillyCooke Consulting. If you are interested in legal services related to the advertising and promotion of FDA-regulated products, please see FDAadLaw.com, which is a sister corporation to PhillyCooke Consulting.

Although the website is currently a bit spartan, the services offered are robust and address all aspects of advertising FDA-regulated products, including concerns related to the Lanham Act, privacy, and FDCA issues.

There has been a surge in demand for gender identity services in the UK over the past five years. Although the current role of pharmacists is limited, their potential contribution within a multidisciplinary team supporting transgender patients is beginning to emerge.

To read the whole article click on the headline

Community pharmacists are to be included in the government life assurance scheme for staff working on the frontline of the COVID-19 pandemic, the health secretary, Matt Hancock has announced.

To read the whole article click on the headline

Johnson & Johnson taps Khan for chief data role; Icon poaches AstraZeneca vet Buck as CMO; Intellia signs on Lebwohl as CMO.

This semester I’ve embarked on an adventure to co-teach a class in the University of Wisconsin-Madison Masters in Biotechnology program. What sold me on the experience was the majority of my responsibility is interacting with second year students on their final major project (essentially their thesis). That said, I will give one lecture, which will be “health

With social distancing, many people are speaking less and their voices sound raggedy. NPR's Scott Simon talks with speech pathologist Sandy Hirsch, about keeping the voice sounding as it should.

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

California DMV will reopen 25 field offices after shutdown

With no coronavirus vaccine in sight, employers and building landlords are turning to tech, design and distancing to keep office workers healthy.

Merchants rejoice they finally reopen businesses and greet customers, with social distancing

California reopening: On Abbot Kinney Boulevard in Venice, the normally bustling shopping district that has been largely vacant amid the coronavirus, there were signs of life Friday as some retailers opened for curbside service.

By Rachael E. Hunt —

By Karin F.R. Moore —