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FDA’s recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufacturers respond to inspection observations, according to a regulatory affairs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
FDA Policy/General
While many health policy experts have expressed concerns that FDA will suffer under the Supreme Court’s Loper Bright decision because judges will be interpreting scientific and health-related terms rather than deferring to FDA’s judgment, University of Missouri law professor Erika Lietzan thinks Loper Bright “may not be
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for BeOne Medicines’ Brukinsa (zanubrutinib) capsules and tablets is false and misleading and thus misbrands the drug. A 5/12 Notice of Violation says the totality of claims and presentations made through visuals in the ad “misleadingly suggests
FDA Policy/General
The departure of FDA commissioner Marty Makary “comes as a positive move after a period of turmoil in the biotech sector, but until a permanent replacement is found, the industry could be under pressure, according to analysts and investors” who were interviewed for a Reuters analysis. The news service has
FDA Policy/General
FDA’s newly announced pilot program for one-day inspectional assessments (see earlier story) may signal a long-term shift toward faster, AI-assisted oversight of regulated facilities, according to an analysis published by law firm King & Spalding. FDA formally announced the pilot program on 5/6, though the
FDA Policy/General
FDA commissioner Marty Makary has resigned after a week of mounting speculation that the Trump Administration was preparing to remove him. The resignation follows several days of reports that President Trump had approved plans to dismiss Makary over conflicts involving flavored vape approvals, abortion-pill policy, vaccine oversight and broader
FDA Policy/General
FDA has issued updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis (TB) treatments, emphasizing the need for shorter, safer and more effective regimens as global drug resistance and HIV coinfection continue to complicate care. The guidance provides recommendations on trial design, safety evaluation and efficacy
FDA Policy/General
Eisai and Biogen say FDA has delayed by three months its decision on a subcutaneous starting-dose formulation of Alzheimer’s drug Leqembi (lecanemab) after the agency requested additional information during its review. The new review action target date for the supplemental BLA is 8/24. The application seeks approval
FDA Policy/General
A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinical trials could shape future agency expectations for how sponsors validate, document and oversee AI systems used in clinical research. In a Request for Information (RFI) issued this month, FDA
FDA Policy/General
President Trump is dismissing reports that say FDA commissioner Marty Makary will be asked to resign soon. Late Friday, Trump told reporters he knew nothing about Makary’s job being in jeopardy. The new week has brought no changes at the agency so far, and Makary continues to be authorizing