FDA Policy/General
Delegates at the American Medical Association's (AMA) annual meeting have voted to support stronger FDA oversight of synthetic peptide products, citing growing concerns about the widespread use of unapproved compounds marketed for weight loss, wound healing, longevity, and other health claims without robust clinical evidence. Peptides — short chains
FDA Policy/General
FDA's expanding use of artificial intelligence tools in regulatory operations is poised to transform how pharmaceutical, biotechnology, and medical device companies prepare for and manage inspections, according to a new analysis by former FDA Office of Enforcement director David Elder. In a guest column published on pharmaceuticalonline.com,
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption has lagged despite years of agency guidance and industry investment. In comments submitted to an FDA request for information on advancing
FDA Policy/General
Drug manufacturers, patient advocates and policy experts used the first FDA public hearing on the Commissioner’s National Priority Voucher (CNPV) program to urge the agency to temporarily suspend the initiative and establish a more transparent framework governing its operation. The 6/4 hearing marked the first formal opportunity for
FDA Policy/General
The House, Thursday evening, passed FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency, including $3.4 billion in discretionary budget authority and $3.7 billion in authorized user fees. The measure was approved by a vote of 213 to 210. Meanwhile, Senate
FDA Policy/General
Former Oncology Center of Excellence and short-time CDER director Richard Pazdur says it’s time to restructure the agency’s organization into various new Centers. As reported by MedCity News, Pazdur appeared on a STAT panel during but apart from the recent annual meeting of the American Society of
FDA Policy/General
FDA has issued an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information. In the just-posted letter, CDER’s Office of Prescription Drug
FDA Policy/General
FDA has issued a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multiple agency requests for manufacturing records related to drug products sold in the U.S. In a just-posted 5/22 Warning Letter, FDA said Aeroflex
FDA Policy/General
Senate appropriators have postponed consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation package forced the Senate Appropriations Committee to suspend its markup schedule for the week. The Senate Appropriations Committee had been scheduled to meet 6/4 to mark
FDA Policy/General
As FDA rolls out a pilot program featuring abbreviated, one-day inspections of lower-risk manufacturing facilities, law firm Hogan Lovells is advising pharmaceutical and medical device companies to maintain full inspection readiness despite the streamlined format. The initiative is intended to introduce shorter, targeted facility reviews designed to complement,
FDA Policy/General
Former FDA commissioner Andrew C. von Eschenbach and former HHS secretary Tommy G. Thompson are urging policymakers to prioritize leadership and institutional stewardship over professional credentials as the search continues for the next FDA commissioner. In an opinion article published Monday, Thompson and von Eschenbach, who both served under president
FDA Policy/General
A new policy report is calling for sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical devices to market could generate trillions of dollars in benefits for patients, innovators and the broader economy. The report, The Multi-Trillion Dollar Opportunity in Reforming the FDA,
FDA Policy/General
An FDA crackdown on allegedly deceptive prescription drug advertising has coincided with a sharp increase in pharmaceutical advertising spending on television and streaming platforms, according to a new report from the Video Advertising Bureau. The report examined advertising trends following FDA’s 9/2025 enforcement initiative, in which the agency
FDA Policy/General
FDA has extended by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-Pick disease, Type C (NPC). The new user fee review action target date is 11/17. The extension follows a 3/18 Beren response to an FDA information request
FDA Policy/General
FDA Matters founder Steven Grossman says it’s hard to imagine a new FDA commissioner taking office before December 2026, and the early months of 2027 would be even more likely. Writing in his online newsletter, Grossman says, “It’s highly unlikely that anyone will be nominated soon, and no
FDA Policy/General
The long-term impact of the Supreme Court’s Loper Bright decision in the health landscape remains unclear, according to an article in the Yale Journal on Regulation. Immediately after the decision was announced, many commentators warned of a coming “seismic” impact. Written by staff and a student at the
FDA Policy/General
FDA’s recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufacturers respond to inspection observations, according to a regulatory affairs analysis published on clinicalleader.com by Rivka Zaibel of ADRES Bio. The draft guidance, which outlines FDA expectations for responses following GMP inspections, emphasizes
FDA Policy/General
Former FDA associate commissioner Peter Pitts, now president of the Center for Medicine in the Public Interest, says the recent resignation of FDA commissioner Marty Makary can be a positive development for American public health if whoever is appointed as his successor can learn from Makary’s mistakes and change
FDA Policy/General
Rare disease advocates issued an open letter Monday urging president Trump and Congress to push FDA to accelerate approvals for treatments targeting fatal genetic disorders, arguing that regulatory delays are costing patients valuable time. The letter, signed by advocates representing families affected by Duchenne muscular dystrophy, Huntington’s disease and
FDA Policy/General
The sudden departure of former FDA commissioner Marty Makary is unlikely to result in major changes to the agency’s approach toward direct-to-consumer (DTC) pharmaceutical advertising, according to comments from industry consultant Bob Ehrlich, CEO of DTC Perspectives. In a newsletter post distributed 5/18, Ehrlich says he
FDA Policy/General
Two prominent drug-policy scholars sharply criticized former FDA commissioner Marty Makary in a commentary published Monday, arguing that his tenure weakened the agency and undermined longstanding scientific and regulatory norms at the agency. In an article published by Health Affairs, Aaron Kesselheim and Jerry Avorn said Makary’s resignation
FDA Policy/General
FDA has replaced the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary, deepening a period of leadership instability that industry observers say could complicate regulatory decision-making for pharmaceutical companies. Tracy Beth Hoeg, who had been serving as CDER acting director, said on social