Drugs
FDA has approved GlaxoSmithKline’s Hibsago (bepirovirsen) to treat chronic hepatitis B virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least six months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B
Devices
FDA has posted the Olympus Warning Letter that the company disclosed last week (see story) based on GMP issues raised during inspections of the firm’s facilities in the U.S., Japan, and Europe conducted in late 2025. According to the letter, FDA inspections at six Olympus Medical Systems manufacturing
Devices
FDA has published two hypothetical examples illustrating how manufacturers of AI-enabled medical devices could modify their products under predetermined change control plans (PCCPs) without submitting a new marketing application for each change. The examples, posted 10/20, describe regulatory approaches for a hospital-specific sepsis alert system and a
Biologics
Richard Forshee, an FDA vaccine safety official demoted during former CBER director Vinay Prasad's tenure, has returned to a senior leadership position at the Center. Forshee announced in a 10/19 LinkedIn post that he had become director of CBER's Office of Biostatistics and Pharmacovigilance (OBPV)
Drugs
FDA has issued new technical specifications for submitting clinical trial data evaluating the effects of drugs and biologics on patients' ability to operate motor vehicles, including standardized datasets for assessing driving impairment. The guidance, Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle, describes how
Devices
Industry executives and FDA officials who participated in a 10/19 panel at The MedTech Conference say initial industry concerns about the new Quality Management System Regulation (QMSR) and its implementation by FDA are easing as companies get more experience with inspections under the new protocol. A Regulatory Affairs Professionals
Drugs
FDA has finalized a guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software that outlines how prescription drug manufacturers should address software applications used with their products, including when claims about the clinical benefits of such software can be included in FDA-approved drug labeling. The guidance addresses mobile
Drugs
FDA has issued a warning letter to Baxter International citing significant GMP deficiencies at its Round Lake, IL, manufacturing facility, including recurring cross-contamination involving cephalosporin antibiotics, inadequate sterile manufacturing controls, particulate contamination and failures to properly investigate sterility test results. The just-posted 9/29 Warning Letter, which followed
Drugs
FDA's move toward accepting one adequate and well-controlled study supported by confirmatory evidence is encountering uneven implementation across review divisions, while sponsors seeking to use real-world evidence to support accelerated approvals continue to face demanding regulatory expectations, according to experts participating in a new FDA Watch
FDA commissioner nominee Heidi Overton played a more prominent role than earlier disclosed in developing the scientific justification for the Trump administration’s controversial decision to reduce the number of routinely recommended childhood vaccines, according to a report by Semafor. Overton, a White House Domestic Policy Council aide, helped draft
Independent news and analysis of FDA regulation, policy and enforcement
FDA has granted GSK accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab-gxly) —treating adults with previously untreated stage II or stage III locally advanced rectal cancer. “At these stages, the cancer has grown into nearby tissue or reached nearby lymph nodes but has not spread to
Disc Medicine says it will resubmit an NDA by year-end for bitopertin in adults and adolescents with erythropoietic protoporphyria (EPP) following just-reported APOLLO Phase 3 favorable data. According to the company, the results demonstrated statistically significant and clinically meaningful benefits across all study endpoints. Earlier this year, FDA
Advanced imaging technologies could help generic drug manufacturers overcome longstanding challenges in demonstrating bioequivalence for complex drug products, potentially reducing reliance on costly comparative clinical endpoint studies, according to a new journal article by FDA researchers. Their review, published in a recent issue of Biophotonics Discovery, examines how modern imaging
FDA has accepted for review a UroGen Pharma NDA for investigational drug UGN-103 (mitomycin), an intravesical solution for treating adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The agency has set a user fee review action target date of 6/14/2027.
FDA has cited Australian medical device manufacturer Saluda Medical Pty. Ltd. for deficiencies involving cleanroom controls, manufacturing procedures and adverse event reporting, according to a just-posted Form FDA-483 related to a 5/25 inspection of its facility in Macquarie Park, New South Wales. In the three-observation Form
FDA has issued a final guidance outlining the identity and safety information manufacturers and distributors should include in new dietary ingredient notifications (NDINs) for dietary supplements. The guidance,“New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI,” finalizes three sections of a 2016 revised
The Trump administration is advancing an interim plan to allow compounding pharmacies to produce certain unapproved peptides despite FDA scientists' findings that available evidence is insufficient to establish their safety and effectiveness. HHS 10/15 submitted an "interim access policy" for peptides to the White House Office
FDA should eliminate “redundant biosimilar trials when rigorous scientific evidence already establishes similarity,” a 10/16 Newsweek opinion piece by Sarfaraz K. Niazi says. The commentary argues that advances in analytical testing now allow manufacturers to demonstrate that proposed biosimilars are highly similar to reference biologics without necessarily conducting additional
FDA is ramping up oversight of clinical trials conducted outside the U.S., placing greater emphasis on data integrity, GMP compliance and the applicability of foreign study results to American patients, according to an analysis by attorneys at Foley Hoag LLP. In a 10/16 client alert, attorneys Matthew Piscitelli
CDRH has issued an early alert after learning that Edwards Lifesciences notifed customers recommending certain delivery systems used for SAPIEN M3 transcatheter mitral valve replacement be removed from where they are used or sold. Affected devices: * Commander M delivery systems (for SAPIEN M3 Transcatheter Mitral Valve Replacement System); Lots: 67718561,
FDA has approved UCB’s Zilbrysq (zilucoplan), a self-administered once-daily autoinjector administration option for treating generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The Zilbrysq autoinjector is designed to automatically deliver a pre-defined dose when activated against the skin. Prior to
The Milken Institute is urging the FDA and other federal agencies to overhaul clinical trial policies, arguing that unnecessarily restrictive eligibility criteria, cumbersome consent requirements and fragmented regulatory oversight are limiting patient participation and slowing medical research. In a 10/13 report, Enabling Access to Clinical Research: An Action Plan