Drugs
Animal Defenders International (ADI) is petitioning FDA to revise its regulations to remove prescriptive references to the rabbit pyrogen test (RPT) for testing drugs for pyrogenic substances and to permit the use of validated non-animal methods instead. The petition says that continuing to refer to the rabbit pyrogen test
Biologics
FDA has ordered Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, after the agency and the company failed to reach agreement on how to address concerns about potentially life-threatening immune reactions. In a just-posted 5/20
Drugs
FDA has appointed Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of the top leadership positions within the agency's inspection and enforcement organization. She replaces Douglas Stearn who retired late last year. Romano, who most recently served
Drugs
Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving feedback from FDA that effectively closed the regulatory path for the drug. The biotechnology company announced June 1 that it had received In meeting minutes from a recent meeting with FDA, the agency
Biologics
FDA has issued a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for products regulated by CBER, offering additional guidance on technical requirements, acknowledgment timelines, and common causes of submission rejections. The FAQ document addresses recurring issues encountered by sponsors submitting biologics
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,
Drugs
Technical negotiations over the next iteration of the Prescription Drug User Fee Act have concluded, setting the stage for broader political and congressional debate over the future direction FDA’s drug review program, according to an analysis published 5/29 by the American Action Forum. In a commentary titled “PDUFA
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
Drugs
FDA has issued a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conjugated therapies, a move the agency said could reduce animal use and speed cancer drug development without compromising patient safety. The document, titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and
Drugs
The International Council for Harmonization has updated its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines, adding new detail on real-time release testing, pharmaceutical quality systems and the role of knowledge management in modern drug manufacturing. The revised Q&
Drugs
FDA has cited BPI Labs for potential cross-contamination risks at its outsourcing facility in Largo, FL, according to an inspection report issued following an April inspection. Agency investigators inspected the facility from 4/6-17 and documented concerns involving cleaning verification procedures used on manufacturing equipment. According to the
Biologics
Replimune plans to resubmit for the third time its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma following what the company described as productive discussions with the agency. It says FDA had aligned with Replimune on a path forward for reconsideration of
Devices
DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the commercial market after being designated for destruction, prompting the company to notify users and coordinate with FDA and law enforcement authorities. The company disclosed that the affected sensors were originally
Devices
FDA has published a final guidance, Content of Human Factors Information in Medical Device Marketing Submissions, to provide a risk-based framework to guide manufacturers on the human factors information that should be included in marketing submissions to CDRH, including 510(k)s, de novo requests, PMAs, and HDEs. The
Drugs
FDA has published two final guidances related to establishing bioequivalence. The first guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, has recommendations for applicants planning to submit bioequivalence (BE) information in ANDAs and amendments and supplements to ANDAs. The guidance describes how to meet the BE
Biologics
Reps. Debbie Dingell (D-MI) and Rich McCormick (R-GA) are calling on FDA to adopt a more effective strategy for identifying sepsis in human tissue donors. In a 5/26 letter to acting commissioner Kyle Diamantas, Dingell and McCormick say they have learned from talking with experts that screening
Devices
FDA this week marked the 50th anniversary of the 1976 Medical Device Amendments by highlighting the law’s lasting role in shaping the modern oversight of medical devices. In a new FDA Voices commentary, CDRH director Michelle Tarver said the amendments created the regulatory framework that continues to govern how
Devices
FDA has issued an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious injury or death if the devices are not updated. The action affects several ventilator models in the Trilogy Evo platform, including the Trilogy Evo, Trilogy EV300, Trilogy
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
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-naïve, high-risk non-muscle invasive bladder cancer, expanding the use of the company’s immunotherapy. The approval covers patients with high-risk non-muscle invasive bladder cancer, or NMIBC, following