FDA Policy/General
The Senate Health, Education, Labor and Pensions (HELP) Committee has announced an 11/18 vote on President Trump's nomination of Heidi Overton as FDA commissioner, setting up a potentially contentious confirmation effort before Democrats take control of the Senate in January. The White House is reportedly preparing an
FDA Policy/General
Among the many issues facing Congress before the end of the year, it should confirm Heidi Overton as FDA commissioner, according to healthcare strategy and consulting firm Medsecurean founder and CEO Kathleen Jaeger, who previously was CEO of the Generic Pharmaceutical Association (now the Association for Accessible Medicines). Writing in
Drugs
A senior executive of Canadian prescription drug supplier CANARX has been arrested on federal charges involving an alleged scheme to illegally import prescription drugs into the U.S., according to CNBC. John Thomas Howard, the company's treasurer and a director, was arrested Sunday on charges including smuggling, conspiracy,
FDA Policy/General
Drugs
Two Democratic senators are seeking information from HHS about safeguards against insider trading and other risks associated with prediction markets that allow investors to wager on clinical trial results and FDA drug approval decisions. Sens. Angela Alsobrooks (D-MD) and Ron Wyden (D-OR) raised the concerns in an 11/
FDA Policy/General
Operational challenges for drug companies related to staffing shortages at FDA are unlikely to be resolved in the near term, according to attorney Nathan Downing (Gardner Law), who was interviewed for a PharmaVoice article. The article says CBER and CDER combined had 1,343 fewer employees in September than in
Drugs
Johnson & Johnson plans to seek FDA approval of Caplyta (lumateperone) for manic episodes associated with Bipolar I disorder following positive results from a second pivotal Phase 3 trial, which demonstrated statistically significant improvements in manic symptoms as early as Day 3. The company said its Study 452 met its
Drugs
BioNTech says it has entered into an agreement to acquire for $205 million an FDA Priority Review Voucher that was awarded to Scholar Rock. The voucher grants an FDA priority review for a single application, which reduces the target FDA review timeline and could lead to expedited approval. BioNTech says
Devices
A new analysis published in Machine Design examines how medical device manufacturers must ensure that engineering design changes are reflected accurately in production records under FDA's Quality Management System Regulation (QMSR). The QMSR, which took effect February 2, 2026, incorporates ISO 13485:2016 into 21 CFR Part 820
Drugs
FDA says its review of records submitted to it in response to an 11/18/2025 request determined that the Nanjing Hanxin Pharmaceutical Technology Co. in Nanjing Shi, Jiangsu Sheng, China, had a significant deviation from current good manufacturing practice (CGMP) requirements for active pharmaceutical ingredients (APIs). An 11/3
Independent news and analysis of FDA regulation, policy and enforcement
FDA researchers say there have been global efforts to streamline biosimilar development of therapeutic proteins (TPs) by reducing reliance on comparative efficacy studies and moving instead toward a comparative analytic assessment plus pharmacokinetics approach. Writing in the open-source Clinical Pharmacology & Therapeutics, the researchers say the new approach is
FDA's updated operating framework for drug facility inspections makes several procedural changes affecting inspection classifications, remote assessments and the use of foreign regulatory inspection reports, according to an analysis by Hogan Lovells. The revised Concept of Operations (ConOps 2.0) replaces the agency's 2017 framework governing
A 4/7-4/17 FDA inspection at the USV Private Limited drug manufacturing facility in Dabhel, Daman, Dadra and Nagar Haveli and Dam, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/2 Warning Letter says the specific violations were: · failure to
BIO says the window to protect America’s biotechnology lead is closing and it offers a seven-step plan to ensure the U.S. remains the global biotech leader for decades to come. In a white paper, “Bio Advance: Securing America’s Biotech Century,” the trade association says the biotechnology
Cingulate says it has resubmitted its NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity disorder. The filing addresses issues the agency raised in a June-issued complete response letter, which reportedly were limited to requests for additional chemistry, manufacturing and controls (CMC) information, according to the company.
FDA is recommending less restrictive patient eligibility criteria and more flexible dose-escalation strategies in early-phase clinical trials for solid tumors, under a new draft guidance addressing common deficiencies identified during the agency's review of INDs. The draft guidance, Early-Phase IND Protocol Recommendations for Solid Tumors,
CDER and CBER are seeking industry input on how to overcome legal, privacy and technical barriers that prevent them from accessing patient-level data used to support product applications containing real-world evidence (RWE). In a request for information (RFI) scheduled for publication in the 11/12 Federal Register, FDA
Former senior HHS adviser Calley Means has accused FDA commissioner nominee Heidi Overton of pressuring former commissioner Marty Makary to approve Moderna's mRNA influenza vaccine despite his scientific objections, alleging that she conditioned assistance on other policy matters on his willingness to approve the product. Means resigned 10/
FDA has issued Novocure a Not Approvable Letter for its PMA for Optune Mya for treating adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation. The said the agency determined that uncertainty around the degree of clinical benefit provided by Optune Mya prevented approval, according
FDA has posted 20 Form 483 inspection records (see below), including reports involving Novo Nordisk, AnaptysBio, Protagonist Therapeutics, Ascendis Pharma and Charles River Laboratories, as the agency continues expanding public access to inspection findings through its electronic reading room. Their availability is part of the agency’s expanded transparency initiative
Democratic control of Congress following the 11/3 midterm elections could bring increased oversight of FDA and HHS, complicate the nomination of a permanent FDA commissioner and turn the 2027 user fee reauthorization into a vehicle for broader health policy legislation, according to FDA policy analyst and former HHS official