Devices
CDRH is accelerating hiring after losing about 22% of its workforce over the past year and a half, including up to 30% of its clinical reviewers and significant numbers of artificial intelligence and digital health specialists. CDRH drector Michelle Tarver disclosed the staffing losses 10/21 at AdvaMed's
Devices
The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points: * several approaches in
Drugs
Researchers from Johns Hopkins and the University of Miami say myelodysplastic syndromes (MDS) therapeutic development is challenged by the syndromes’ biological diversity and regulatory risk. Writing in Blood Advances, the researchers say MDS is “ideal for FDA to implement flexible, biology-informed regulatory pathways. Establishing such frameworks in MDS could
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the draft PDUFA 8 commitment letter. The PhRMA comment says PDUFA 8 will help ensure the long-term sustainability of FDA’s human drug review program and strengthen agency capabilities by: * enhancing the efficiency of the drug review process
Biologics
A Georgia federal court has determined that FDA misread its own regulations in determining that a MiMedx wound care powder product was not a human cell, tissue, or cellular- or tissue-based product (HCT/P) because it was not minimally manipulated. Attorneys Vanessa Hampton and Alan Minsk (Arnall Golden Gregory)
Drugs
FDA has released the Form FDA-483 with eight observations from a 6/8-6/17 inspection at the Jubilant HollisterStier drug manufacturing facility in Spokane, WA. The inspection observations were: * component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for
Drugs
FDA has released the Form FDA-483 with one observation from a 5/12-5/19 inspection at the Lonza Bend manufacturing facility in Bend, OR. The inspection observation was: * failure to thoroughly review any unexplained discrepancy, whether or not the batch had already been distributed.
Drugs
Roivant and Priovant Therapeutics have announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). The drug met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies, according to the company. It also achieved “statistically significant and clinically meaningful benefit on
Drugs
FDA investigators have cited Catalent CTS for deficiencies in contamination prevention and microbial monitoring at its Kansas City, MO, drug manufacturing facility, including multiple water leaks and a failure to investigate a potentially objectionable microorganism detected in a manufacturing system. The findings were detailed in a just-posted Form FDA
FDA has accepted for review a Unicycive Therapeutics NDA resubmission for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The submission addresses a June Complete Response Letter (CRL) that cited deficiencies previously identified at a third-
Independent news and analysis of FDA regulation, policy and enforcement
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
Sen. Jim Banks (R-IN) is leading a group of senators urging FDA to ramp up enforcement against online vendors using “for research use only” labeling to market unapproved drugs and active pharmaceutical ingredients (APIs) to consumers, citing growing concerns about counterfeit versions of Eli Lilly’s investigational weight-loss
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
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
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
FDA has released an Olympus Warning Letter, which the company disclosed last week (see story), citing 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 sites,
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
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, which
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
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
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