FDA Policy/General
FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’
FDA Policy/General
FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few
Devices
FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued
Drugs
FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing
Biologics
FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) for treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. The agency set a user fee review action target date for upcoming
Drugs
FDA says it has directed Takeda to add a Boxed Warning to the labeling for its Adzynma, a recombinant ADAMTS13 enzyme replacement therapy approved for congenital thrombotic thrombocytopenic purpura (cTTP). An agency online notice says Adzynma has been associated with the development of neutralizing antibodies that can prevent the drug
FDA Policy/General
FDA commissioner nominee Heidi Overton pledged to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific independence during her Senate confirmation hearing Thursday, while facing pointed questions from lawmakers about vaccine safety, medication abortion, tobacco regulation and political interference in FDA decisions. Overton, a White House
Drugs
FDA has approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for controlling high blood sugar in adults with Type 2 diabetes when used along with diet and exercise. Onswik is designed to deliver steady basal insulin levels over a full seven days, the
Devices
Drugs
Independent news and analysis of FDA regulation, policy and enforcement
On the eve of FDA commissioner-nominee Heidi Overton’s Senate confirmation hearing, Former FDA head Scott Gottlieb appeared on CNBC to offer his ringing endorsement of President Trump’s pick to lead the agency. Gottlieb cited as being positive her White House experience, relationships with administration officials, and her
FDA has accepted a letter of intent (LOI) for a wearable sensor-based digital outcome measure designed to assess foot drop severity and gait impairment in patients with Charcot-Marie-Tooth disease type 1A (CMT1A), marking the first digital health technology for a rare neurological condition accepted into the agency&
FDA says efforts by CDER scientists to develop a systematic plasma proteomic biomarker framework can accelerate drug development by providing early mechanistic insights into therapeutic effects and enabling more informed decision-making in clinical trials through the selection of robust, biologically relevant biomarkers. An online post says that to evaluate
Four stakeholders are suggesting ways FDA could improve its draft guidance on substantial evidence of effectiveness for human drug and biological products. The Center for Science in the Public Interest (CSPI) says it “opposes any shift in the regulatory standard to a one-trial default….” While the draft does not
An FDA advisory committee voted Wednesday to recommend approval of Grail's Galleri multi-cancer early detection blood test, voting unanimously, 10-0, that the test is safe, 6-4 that it is effective, and 7-2, with one abstention, that its benefits outweigh its risks for screening adults
A 12/1-12/11/2025 FDA inspection at Specialty Health Products in Phoenix, AZ, found multiple violations in the firm’s illegal manufacturing of colonic irrigation systems and speculum kits. A just-released 7/7 Warning Letter lists these Quality System Regulation violations: * failure to establish and maintain design
FDA says a meta-analysis conducted by CDER scientists found that pharmacokinetic similarity studies provided useful information to descriptively evaluate the immunogenicity and safety of biologics, and that comparative clinical studies did not appear to be more definitive. In an online post, the agency says the scientists suggest that their
A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operator from receiving, storing or distributing FDA-regulated products until it corrects persistent insanitary conditions, including severe rodent and pest infestations that placed drugs, medical devices, food, and cosmetics at
CBER has issued a Standard Operating Policy and Procedure (SOPP) as a guide for Center staff in scheduling and conducting regulatory meetings between individuals in the Center and representatives of regulated companies and/or individual sponsor-investigators to address issues relating to product development. The SOPP applies to meetings for
FDA has released the Form FDA-483 with three observations from its 8/10-8/19 inspection at the STAQ Pharma Ohio outsourcing facility in Columbus, OH. The inspection observations were: * failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test
A 3/31-4/3 FDA inspection at the kdc/one Chatsworth drug manufacturing facility in Chatsworth, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/8 Warning Letter says the violations were: * failure to have, for each batch of drug
A machine learning-based approach to FDA's 510(k) medical device clearance process could reduce device recalls by nearly one-third while cutting the agency's regulatory workload by more than 40%, according to a study published in Management Science. The study evaluated a proposed system that