KFF News, Arthur Allen, September 12-16, 2025

Under President Donald Trump, leaders at the US Food and Drug Administration (FDA) are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny.

The agency “would like to get away” from assembling panels of experts to examine and vote on individual drugs, because “I don’t think they’re needed,” said George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research. He relayed the message last week at a meeting of health care product makers and to an FDA advocacy group.

In addition to being redundant, Tidmarsh said, advisory meetings on specific drugs were “a tremendous amount of work for the company and for the FDA. We want to use that work and our time to focus on the big questions.”

The FDA’s advisory committees were created in their current form by a 1972 law aimed at expanding and regulating the government’s use of experts in technical decisions. They’re periodically summoned for advice, including to review evidence and vote on whether the FDA should approve drugs, vaccines, and medical devices, often when FDA officials face a difficult decision.

FDA actions have traditionally aligned with committee votes. A departure can provoke controversy and public debate, as was the case with the split 2021 decision on whether to approve the Biogen drug Aduhelm to treat Alzheimer’s disease.

The FDA approved the drug despite a “no” vote from its advisory committee, whose members felt the medicine did little to treat the disease. The conflict over Aduhelm laid bare the FDA’s struggle to reconcile pressure from industry and desperate patients with its rigorous evaluation of drug risks and benefits.

Tidmarsh said the committees would still be consulted on general issues like how to regulate different classes of drugs. But meetings on specific drugs, in which experts plow through piles of studies and hours of testimony from FDA and company officials, were mainly useful, he said, because they allowed the public to see how the FDA worked.

This month, the FDA began publishing the “complete response letters” it sends to companies when it declines to approve their products. Releasing the letters, which previously required filing requests under the federal Freedom of Information Act, promotes a level of transparency akin to the advisory meetings’, Tidmarsh said.

Advisory committee meetings on individual drugs “are redundant when you have the complete review letters,” he told KFF Health News in a brief interview after appearing at the health care products conference.

Former FDA officials and academics who study the agency disagree. The meetings help FDA scientists make decisions and increase public understanding of drug regulation, and abandoning them doesn’t make sense, they said.

Tidmarsh’s reasoning is “hard to follow,” former FDA Commissioner Robert Califf told KFF Health News. “It’s extremely useful for people inside FDA to find out what other experts think before they make their final decisions. And it’s important to do that in a way that enables the public to understand the points of view.”

“Experts might ask questions of the company or FDA that neither of them thought of on their own,” said Holly Fernandez Lynch, an associate professor of bioethics and law at the University of Pennsylvania. “The public has few other opportunities to comment about FDA decisions.”

Spokespeople for FDA and the Health and Human Services Department did not respond to repeated requests for elaboration on Tidmarsh’s comments.

Califf at times disagreed with advisory committees as commissioner of the agency and once floated the idea that it might be better if they deliberated but did not vote on products. Still, while “maybe someone can come up with a better one, I always thought it was an amazing system,” he said.

[….]

The advisory committees are “an important resource” for the FDA, said Sarah Ryan, a spokesperson for the Pharmaceutical Research and Manufacturers of America. “They can play an important part of the rigorous human drug review process we have in the U.S.”

[….]

The changes Tidmarsh described are already playing out on the ground. The FDA has held only seven advisory committee meetings since Trump reentered the White House, compared with 22 over the same time frame last year. Officials say they will now release complete response letters as they are sent, and published a batch of 89 earlier this month.

Makary has, to some extent, replaced the advisory committees, whose members have traditionally been vetted for expertise and biases and are required to deliberate in public, with panels of handpicked scientists who support his views on subjects such as hormone replacement therapy and antidepressants.

Diana Zuckerman, an FDA watchdog, attended the July hormone replacement therapy panel that considered the FDA’s black box warning listing dangers of the treatment. Makary had wanted the warning removed and packed the panel with like-minded experts.

The event was hastily called with no opportunity for the public to review discussion materials or comment on them, she said.

“All that was transparent was that they didn’t want to hear from anyone who disagreed with them,” said Zuckerman, who leads the National Center for Health Research.

Before becoming commissioner, Makary pushed for more advisory committee meetings. In early 2022, he blasted the FDA’s decision to approve COVID-19 boosters for children ages 12 to 15 without consulting its Vaccine and Related Biological Products Advisory Committee. Makary posted on the social platform X at the time, “It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board.”

But Tidmarsh seems to disagree.

Instead of asking an advisory committee to vote in favor of or against a Duchenne muscular dystrophy drug, for example, he said the FDA would be better served by a committee studying the best way to evaluate such drugs, such as which outcomes, or endpoints, to measure. “Is this endpoint correct for Duchenne muscular dystrophy? That’s an important question that cuts across many different companies,” he told KFF Health News.

FDA official Vinay Prasad canceled a planned July advisory committee meeting to discuss a Duchenne drug made by the biotech company Capricor Therapeutics. The FDA later published its complete response letter to Capricor, which then published its own letter of response to the FDA. Prasad was later pushed out and rehired with fewer powers.

An advisory committee meeting could have worked through the drug’s risks and benefits in a calmer, public, less politicized atmosphere, Ramachandran said.

[….] 

That’s why Tidmarsh’s comments “come as a complete surprise,” said Genevieve Kanter, an associate professor of public policy at the University of Southern California, who wrote commentary accompanying the study. 

[….]

“Another theory is that this decision is strategic,” she said, “in terms of consolidating power in the agencies so that you are no longer accountable to outside experts or the public.”

To read the entire article, click here https://www.cancertherapyadvisor.com/news/under-trump-fda-seeks-to-abandon-expert-reviews-of-new-drugs/

Elise Reuter, MedTech Dive, August 5, 2025

Margaret Manto, NOTUS, June 26, 2025

Health Secretary Robert F. Kennedy Jr. has made ending “corporate capture” of the federal health agencies a key tenet of his plan to eradicate what the MAHA Commission Assessment describes as “threats to American childhood that have been exacerbated by perverse incentives.”

But health care lobbyists, regulatory experts and advocates for reduced industry involvement all told NOTUS the same thing: So far, Kennedy’s words don’t match his actions.

“The rhetoric is quite different, but it doesn’t seem like the reality is obviously different,” said Diana Zuckerman, president of the National Center for Health Research, who has criticized the Food and Drug Administration’s funding structure that relies on collecting fees from the companies whose products it regulates. “There’s all kinds of conflicts of interest that have been absolutely ignored by HHS and, as far as we can tell, still are.”

Since ascending to the top of the U.S. public health system, Kennedy has made grand gestures towards his supposed goal of clamping down on corporate influence at the Department of Health and Human Services. He’s held press conferences to tout agreements made with food producers to end the use of certain synthetic food dyes and with insurance companies to speed up the prior authorization process, both of which companies have lobbied against for years.

But these agreements have all been entirely voluntary. In the case of the food dye announcement, that was a direct result of industry influence, said one lobbyist granted anonymity to speak frankly.

“Their biggest win was not real,” the lobbyist said.

[….]

“Secretary Kennedy’s commitment to eliminating undue corporate influence and restoring public trust in health policy is backed by decisive action. Under the Secretary’s leadership, HHS has taken concrete steps to increase transparency, strengthen ethical standards, and prioritize the health and well-being of the American people over industry profits,” the spokesperson wrote.

But the MAHA report, which took aim at a range of public health interventions that the MAHA movement is suspicious of, including vaccines and ultraprocessed foods, was noticeably light on criticism of the agriculture industry and pesticide use — which Kennedy has pledged to reform.

In a hearing last month before a subcommittee of the Senate Committee on Appropriations, Kennedy assured senators that he would “not do anything to jeopardize that business model.”

Other than reworking their pitches to use new, more MAHA-friendly language, companies and the lobbyists who work for them haven’t had to do much to adapt to the new HHS leadership, the lobbyist said.

“I haven’t noticed anything different at all,” they said. “I don’t know anybody who’s had a problem getting a meeting.”

[….]

Since these meetings, HHS has embarked on policies that both advance the MAHA movement’s public health goals and provide potential benefits to industries deemed acceptable.

Earlier this month, STAT News reported that HHS put out a call for proposals for a “bold, edgy” public messaging campaign to “inspire and empower Americans to reclaim control over their health.” The request specifically asks for proposals that highlight health wearables as “cool, modern tools.”

“My vision is that every American is wearing a wearable within four years,” Kennedy said during a congressional hearing this week.

Other policy decisions seem poised to benefit not just certain niches of the health care industry, but key players within the MAHA movement. In early June, the Food and Drug Administration declined to contest a court ruling that overturned a 2024 FDA rule regulating laboratory-developed tests.

The agency had previously argued that increased regulation was necessary to “better protect the public health by helping to assure the safety and effectiveness” of tests that are manufactured and used by a single laboratory, as opposed to commercially available in-vitro diagnostics that are used by labs nationwide and which the FDA requires to be thoroughly verified and validated.

[….]

The FDA is the main arbiter of which drugs, medical devices and food additives are allowed to enter the U.S. market. It has long borne the brunt of Kennedy’s and other HHS critics’ “corporate capture” accusations thanks to its user-fee funding structure, where companies pay to have their products reviewed by the FDA and help supplement the agency’s congressionally allocated funds.

Corporate influence watchdogs are scrutinizing other recent FDA shifts, too.

While FDA commissioner Marty Makary promised “radical transparency” during his confirmation process, earlier this month he announced a nationwide “listening tour” where he will meet with pharmaceutical and biotech CEOs to solicit their input on “how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.”

Companies are required to have an active drug or device application with the FDA in order to send a representative to meet with Makary.

“The listening tours usually actually involve listening to the public, not just listening to each other,” said Zuckerman. “In the past they’d have it at some university or medical center or something, a public meeting. Anybody could sign up to attend, anybody could sign up to ask questions or make comments.”

The HHS spokesperson said the listening tour is intended to “break through the bureaucratic echo chambers that have long hindered the FDA” and that “direct engagement with regulated industry is essential for real reform and accountability.”

Jessica Karins and Maaisha Osman, Inside Health Policy News, April 17, 2025

Annie Burns-Pieper, CTV News, April 13, 2025

Canadian health experts warn the fallout from thousands of job cuts at the U.S. Food and Drug Administration on April 1 could disrupt the flow of safety information on drugs, medical devices, and food to Canada.

For years, Canadian agencies responsible for monitoring food and pharmaceutical safety have worked closely with regulators around the world. The U.S. Food and Drug Administration’s (FDA) vast resources and global influence have played a role in informing decisions in Canada on issues such as safety warnings and recalls of dangerous foods and drugs from the market.

However, sweeping changes to the FDA since U.S. President Donald Trump took office could impact the benefits Canada derives from this historic collaboration, reducing the quality and availability of information about harmful drugs and food products—potentially allowing serious health risks to go undetected and products to remain on the market longer.

The U.S. Department of Health and Human Services (HHS), now headed by Robert F. Kennedy Jr., laid off 10,000 workers as part of Elon Musk’s Department of Government Efficiency task force. The department plans to cut 3,500 jobs directly from the FDA.

A ‘huge problem’

While a memo on the restructuring claimed that layoffs wouldn’t affect reviewers or inspectors of drugs, medical devices, or food, reporting in the U.S. revealed that these areas are being impacted. Reported job losses include lab scientists who tested food for contaminants including deadly bacteria, scientists at drug safety labs, and staff in the drug inspections and investigations office, among many others.

“I think this is a huge, huge problem,” said Matthew Herder, a professor of law and medicine at Dalhousie University who specializes in regulation of pharmaceuticals. He told CTVNews.ca in an interview that Canada has long benefited from the FDA’s size and reach.

[….]

Canada has historically benefited from U.S. post-market surveillance—the ongoing monitoring of drugs and medical devices after they’ve been approved—to detect safety issues that may not have surfaced during clinical trials. “They just have vastly more resources,” said Herder. “The chances of us picking up something before the U.S. are very slim.”

For example, in 2017, Health Canada issued a safety review and letter to health professionals for commonly used antibiotics, fluoroquinolones, following a review by the FDA, warning of a potential risk of “disabling side effects” from tendonitis or nerve damage.

In 2019, Health Canada recalled surgical mesh for transvaginal repair of pelvic organ prolapse following a U.S. recall. Canadian women had reported debilitating side effects, including urinary problems, mobility challenges, emotional distress, and discomfort during sex associated with this medical device.

Diana Zuckerman, the president of The National Center for Health Research in Washington, D.C, called the staff cuts at the FDA a disaster: “you can’t cut 20% of their staff and think it’s not going to have a tremendous impact.”

She said in an interview with CTVNews.ca that post-market surveillance is already under-resourced and worries it will be weakened further by the cuts.

Herder said less surveillance of approved drugs is particularly concerning given the trend in recent years of letting more drugs into the market with less evidence. “If we’re losing the oversight that the FDA offers globally or losing even the percentage of it, that is really terrifying.”

CTVNews.ca asked Health Canada, responsible for drug and medical device safety, about the concerns raised by experts that a diminished FDA could pose risks to Canadians, but the agency declined to comment.

Canadian outbreaks could ‘go totally unnoticed’

Canada has also long collaborated with American agencies for food safety. Keith Warriner is a food safety professor in the Department of Food Science at the University of Guelph. Despite the Buy Canadian movement, he believes imports from the U.S. will continue to be a significant source of food in Canada.

He said American agencies, including the FDA, Centers for Disease Control and Prevention, and the United States Department of Agriculture, have been particularly good at surveillance, and Canadians have benefited from information sharing.

“When an outbreak occurs, they’re pretty hot on it. In Canada, we could get outbreaks that go totally unnoticed,” Warriner told CTVNews.ca. Often recalls and alerts originate with American products and are adopted in Canada, meaning that a delayed response in the U.S. could also impact Canadian consumers.

His biggest concern about the changes to the FDA is that the U.S. might reduce food safety surveillance, and “if they cut back on that, then it’d be outbreaks running rampant.” He suspects the deep cuts will lead to fewer recalls due to a decrease in outbreak detection.

[….]

Dr. Joel Lexchin is concerned that, given the climate of U.S.-Canada relations, pharmaceutical information sharing could be reduced. The retired emergency room doctor and a former professor at York University who has been researching pharmaceutical policy in Canada for more than 40 years told CTVNews.ca, “if the FDA keeps data to itself, unsafe products may remain on the Canadian market for longer than they currently do.”

He would like to know how the historically collaborative relationship between the FDA and Health Canada is currently operating and how Health Canada plans to fill in any gaps left by potential changes in information sharing.

[….]

To read the entire article in CTV News, click here https://www.ctvnews.ca/health/article/amid-deep-cuts-to-the-us-fda-experts-warn-canadians-could-lose-vital-safety-information/

Lizzy Lawrence, Sarah Todd, and Matthew Herper, STAT News, March 27, 2025

WASHINGTON — Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.

The Health and Human Services Department on Thursday announced a sweeping plan to cut 10,000 jobs and consolidate operations across its sub-agencies. FDA drug, medical device, or food reviewers and inspectors will not be among those fired, according to an HHS fact sheet. Instead, the cuts will target employees working on policy, human resources, information technology, procurement, and communications. The administration will start sending notices to employees on Friday, with the terminations coming into effect on May 27.

The sparing of FDA reviewers may put some industry leaders at ease, but other FDA experts are concerned that firing the thousands of employees supporting their work will make it more difficult for the agency to promote innovation and protect public health. The layoffs will shrink the FDA by almost 20%.

“Even though the intent is not to affect product reviews or or inspections, inevitably, by cutting back on services, there will be an impact,” said Wayne Pines, former associate commissioner for public affairs for the FDA.

The cuts align with Elon Musk and the U.S. DOGE Service’s mission to trim the workforce. But they also represent HHS Secretary Robert F. Kennedy Jr.’s goal to exert more control over the sub-agencies he oversees. Even high-level FDA officials appear not to have been briefed on the cuts, sources told STAT, indicating a tightening of command within HHS. The power shift is clear on the media side, as STAT’s media requests continue to be redirected from FDA to the HHS press tea

[….]

This is not the administration’s first attempt to shrink HHS. In February, Musk laid off thousands of probationary workers, including people working on food safety, AI regulation, and preventing the spread of infectious diseases. After pushback from the device industry, the administration rehired some FDA reviewers a week later. A federal judge has since paused all the probationary layoffs. The administration has also offered civil servants $25,000 to leave their posts, and instated a strict work-in-office work policy that has alienated some employees.

Several employees at FDA have told STAT that morale is extremely low, particularly given the agency’s leadership vacuum. The Senate on Tuesday confirmed Marty Makary as FDA commissioner, but he hasn’t yet been sworn into the role. Lawmakers pressed Makary at his confirmation hearing about the DOGE cuts at the FDA, urging him to personally assess personnel before any major culling of the agency.

“If confirmed as commissioner, you have my commitment that I will do an assessment of the staffing and personnel at the agency,” Makary said. It is unclear if he will get the chance.

[….]

Pines noted that efforts to consolidate HHS and FDA are not new; as the former head of communications, he’s witnessed several reorganizations. But he said the level of consolidation is unprecedented, and could significantly impact the way FDA operates.

“The concept of consolidation, every secretary has had their point of view about that,” Pines said. “But there’s never been a change like this at FDA anywhere near this scale.”

The cuts seem “too big, too fast. I agree with RFK Jr., who says this is going to be painful, and I’m not sure what the rewards are going to be,” said Diana Zuckerman, a former congressional investigator for FDA approval standards and president of the nonprofit think tank National Center for Health Research. “These kinds of changes usually are extremely disruptive and not productive for at least a few years.”

Zuckerman wondered whether the cuts will ultimately impede Kennedy’s ambitions to reshape U.S. regulation of food. Kennedy has said he wants to focus on food labeling and fixing the “generally recognized as safe,” or GRAS, loophole in FDA review of food ingredients, as well as improving the quality and supply of infant formula. 

“I think those are important,” Zuckerman said. “Who’s going to do that?” Even if the people working on those specific issues are not affected by the cuts, “usually you’d need more people working on those kinds of issues.” 

Around 46% of the FDA’s total budget comes from “user fees” paid by industry to speed up product reviews. The FDA can use this money to fund employees who review medical product applications, conduct research to speed up regulatory decisions, inspect facilities, and evaluate products’ safety after they hit the market. The HHS reduction in force will likely spare most of these employees.

But the cuts won’t make their lives any easier. One FDA employee told STAT they are starting to lose access to medical journals they rely on for regulatory research. Gutting administrative personnel and cutting down on agency resources may slow down reviewers and worsen morale.

“Eliminating those people, it’s just going to be more difficult from a personnel perspective,” said Brian Ravitch, a regulatory consultant at Olsson Frank Weeda who worked for the FDA for 25 years.

To read the entire article, click here https://www.wsj.com/politics/policy/rfk-jr-plans-10-000-job-cuts-in-major-restructuring-of-health-department-bdec28b0

David Lim, Politico, February 24, 2025

Pfizer has tapped the FDA’s former top drug regulator, Dr. Patrizia Cavazzoni, as its chief medical officer, the pharmaceutical company announced on Monday.

Allies of the new health secretary, Robert F. Kennedy Jr., seized on the news, pointing to Cavazzoni’s hire as proof of the revolving door with industry that Kennedy has long alleged is corrupting the FDA’s priorities and preventing it from taking a more skeptical view toward vaccines and other drugs.

“This is the core rot in American regulation,” Dr. Vinay Prasad, a professor at the University of California, San Francisco who is in the running for a job in Kennedy’s department, wrote in a blog post. “I find this behavior abhorrent, and it should be criminal. Mr. Kennedy has vowed to stop this, and I welcome that.”

The hire also drew criticism from public health advocacy groups that aren’t aligned with Kennedy.

“Cavazzoni’s move demonstrates that the revolving door between the FDA and the industries it regulates is alive and well,” said Dr. Robert Steinbrook, the director of Public Citizen’s Health Research Group.

Before joining the FDA in January 2018 as the deputy director of operations in the agency’s Center for Drug Evaluation and Research, Cavazzoni worked at Pfizer leading clinical sciences and development operations.

[…]

Cavazzoni will formally start the new role on March 1, according to Pfizer spokesperson Amy Rose. She will report to Dr. Chris Boshoff, Pfizer’s chief scientific officer and president of its research and development arm. Endpoints News and STAT first reported news of Cavazzoni’s new job.

Diana Zuckerman, the president of the National Center for Health Research, a nonprofit, said she’s watching to see who chooses Cavazzoni’s permanent replacement as the nation’s top drug regulator: Trump’s pick to lead the FDA, the as-yet-unconfirmed Johns Hopkins University surgeon Dr. Marty Makary, or Kennedy, a longtime critic of vaccination, or someone else in the administration.

“This is the problem with this revolving door at FDA, people go from industry to FDA and then while they are at FDA they still seem to be strongly aligned with industry and then when they leave FDA they go back to industry,” Zuckerman said. “It raises a lot of questions about how objective they are when they are supposed to be working for the public at the FDA.”

Read the article in Politico here: https://subscriber.politicopro.com/article/2025/02/pfizer-hires-fda-drug-regulator-cavazzoni-sparking-revolving-door-debate-00205735?site=pro&prod=alert&prodname=alertmail&linktype=article&source=email.

Elise Reuter, MedTech Dive, Jan. 27, 2025

Two days into the Trump administration, several webpages covering diversity in clinical trials, annual medical device reports and LGBTQ+ information were removed from the Food and Drug Administration’s website. It’s not clear if the changes are temporary or if the pages will be restored.

When asked about the removed webpages, an FDA spokesperson directed MedTech Dive to contact the Department of Health and Human Services. The HHS did not respond to multiple requests for comment.

“It is definitely not typical,” said Diana Zuckerman, president of the National Center for Health Research. “From one administration to another, certain things are reviewed and taken down. I don’t think ever [in] the first week of the administration.” 

Other federal websites have scrubbed pages on diversity, equity and inclusion; mentions of the acronym LGBTQ+; federal policies on people with disabilities and abortion search results, according to reporting by Politico, NBC News, the Washington Post and NPR. The Trump administration has also frozen health research grants, according to STAT News.

Some of the removed FDA pages related to efforts around diversity, gender and health equity.

“Surely there’s someone who’s knowledgeable enough about science to understand the importance of diversity in clinical trials,” Zuckerman said of the Trump administration. 

A recent draft guidance from the FDA’s Center for Devices and Radiological Health providing recommendations for medical device sponsors to consider sex- and gender-specific data in clinical studies was removed. The guidance was released on Jan. 6, and the page was last archived to the Internet Archive’s Wayback Machine on Jan. 14. As of Monday, the guidance was available through the Federal Register’s website.

Last week, President Donald Trump issued a raft of executive orders targeting DEI programs. One order called for the removal of federal DEI mandates, policies, programs, preferences and activities “under whatever name they appear.” Trump also issued an order stating that official U.S. policy recognizes two sexes as assigned at birth, male or female. The order contradicts medical groups, including the American Medical Association, that recognize sex and gender identity as a spectrum.

Although guidances are not legally enforceable, “it is troubling that this is happening,” said Michael Abrams, a senior health researcher at consumer advocacy nonprofit Public Citizen.

Most of the information in the guidance was “common sense,” said Madris Kinard, CEO of Device Events, a company that tracks the FDA’s adverse event reports and recalls.  “This is research on making sure you include the right populations that are relevant to the device that you’re approving or clearing,” Kinard added.

Several of the CDRH’s annual reports were also pulled from the center’s site Wednesday afternoon. CDRH released and posted its 2024 report Jan. 17.

Meanwhile, Dorothy Fink, the HHS’ acting secretary, ordered a pause on Jan. 21 on communications from health agencies, according to the Associated Press.

“We count on the HHS especially to be transparent and a scientific voice so doctors and patients are informed about emerging and existing prevailing health trends,” Public Citizen’s Abrams said.

A page on increasing clinical trial participation for the LGBTQ+ community was removed as of Monday. It was last archived on Jan. 18

[….]

A page for the CDRH’s Health of Women Program was also removed as of Monday. It was last archived on Dec. 24, 2024. The program was started in 2016 to address sex- and gender-specific issues in medical technology design and performance.

Eileen Barrett, a hospitalist and president-elect of the American Medical Women’s Association, said having women and LGBTQ+ people represented in clinical trials “should be apolitical.”

“Nobody wants the patients to get worse care because we aren’t acknowledging the entire context in which they’re experiencing their health and also the way they experience healthcare delivery,” Barrett said.

Webpages were also down on the CDRH’s recent Home as a Health Care Hub initiative, including an announcement for the program and a listening session the agency held last year. The program was launched in April by Michelle Tarver, who was named CDRH director in October. The program is intended to provide resources for devices to be designed with a home environment in mind, starting with a focus on diabetes.

Another removed page referenced a virtual public meeting on real-world evidence slated for Jan. 30.

[….]

Zuckerman said the communications blackout makes a “bad impression,” raising questions about whether the public will be notified about important recalls or product approvals.

“I think there’s so much that needs to improve with transparency, and I see things going backwards,” Device Events’ Kinard added

To read the entire article in MedTech Dive, click here.