FDA Policy/General
Democrats flipping both chambers of Congress in the 11/3 midterm elections has complicated the confirmation prospects of President Trump's nominee to lead FDA, Heidi Overton, while setting the stage for increased congressional scrutiny of the agency's drug approval decisions, vaccine policies and regulatory independence. The
Drugs
FDA has issued Vanda Pharmaceuticals an untitled letter citing a television advertisement for its motion sickness drug Nereus (tradipitant), alleging that a high-speed car chase and other dramatic scenes misleadingly portray the drug's effectiveness and safety while interfering with viewers' understanding of its risks. The agency
Drugs
In its latest five-year report, covering 7/1/2020 to 6/30/2025, FDA says the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) have “fundamentally transformed the landscape of pediatric drug development, delivering substantial benefits to children and families across the United States
enforcement
FDA referenced artificial intelligence in just seven of 3,011 Warning Letters issued between 1/2022 and 9/28/2026, with only one letter explicitly identifying a company's use of AI as a regulatory violation, according to a new study published in Discover Pharmaceutical Sciences. The retrospective analysis,
Drugs
President Trump 11/3 signed into law legislation extending federal programs supporting access to investigational amyotrophic lateral sclerosis (ALS) treatments through fiscal 2031 and requiring FDA to develop a new five-year action plan for rare neurodegenerative diseases. The bipartisan Accelerating Access to Critical Therapies for ALS Reauthorization Act of
Drugs
International researchers say their review of 26 drugs for 35 pediatric indications given accelerated approval by FDA between 2000 and 2020 suggests there are persistent challenges in generating timely, high-quality pediatric evidence under the accelerated approval pathway and emphasizes the need for innovative data-driven strategies to strengthen confirmatory
Drugs
Ahead of its 11/10 annual meeting, which will focus on early-phase oncology drug clinical trial development, Friends of Cancer Research (FCR) has issued three white papers for discussion during the day. Session 1, on risk-based nonclinical strategies to support early-phase development, will use a paper entitled
Drugs
FDA says Amneal Pharmaceuticals of New York, in Brookhaven, NY, has been using unapproved Red #2 and Red #3 color additives in the manufacturing of prescription drugs. A just-released 10/27 Notice of Violation says the agency found the violations in its review of Amneal records that FDA requested
Drugs
AstraZeneca has petitioned FDA to withhold approval of a Cipla ANDA for proposed new strengths of generic Lynparza (olaparib) tablets unless the generic company provides additional evidence addressing formulation differences, tablet size and potential medication errors. Lynparza, a PARP inhibitor approved for certain ovarian, breast, pancreatic and prostate cancers, is
Drugs
Former CDER director George Tidmarsh has filed a defamation lawsuit against Aurinia Pharmaceuticals and biotech investor Kevin Tang, alleging that they provided false accusations of bribery and abuse of regulatory authority to senior FDA officials a year ago, triggering his removal from the agency. The 23-page complaint (see below)
Independent news and analysis of FDA regulation, policy and enforcement
Drug sponsors are not required to submit model analysis plans in advance under the new ICH M15 guideline on model-informed drug development (MIDD), and models that fail to meet predefined validation criteria are not necessarily disqualified from supporting regulatory decisions, international regulatory experts said during an 10/29 FDA-
FDA has issued an Early Alert concerning a potentially high-risk defect in Compact Medical's ButterflyBVM bag-valve-mask resuscitators that could cause inadequate ventilation, hypoxia, serious injury or death. The agency said Compact Medical is removing certain lots of the single-use devices and requiring additional pre-
FDA says its review of records and products submitted by Guangdong Bangze Medicine Co., Ltd., in Guangdong Sheng, China, in response to an agency 1/20 request, determined there were significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s production of over-the-
Harmed Americans for Reform in Medical Device Safety (HARMS) is asking FDA to confirm that robotic surgical systems are investigational when used in nipple-sparing mastectomies. The advocacy group’s 10/31 petition says clarification is needed because of an apparent inconsistency between the agency’s clearance of the da
At the 13th Annual Symposium on Pediatric Device Innovation, CDRH associate director for the Total Product Life Cycle Advisory Program (TAP), April Marrone, presented tips on the most effective way to use the TAP accelerator, which has already enrolled about 160 innovative devices. An online Medical Design & Outsourcing post
A 6/2-6/6 FDA inspection at the Pritam International Private Limited drug manufacturing facility in Uttarakhand, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/27 Warning Letter says the agency also determined that the firm contract manufactures an over-the-
FDA's stepped-up enforcement against prescription drug advertising may be having an unintended consequence: Some pharmaceutical companies are becoming more willing to accept promotional risks because the agency has issued so many enforcement letters without consistently escalating to more serious actions, attorneys said during a recent Food and
FDA's use of advisory committees has declined since 2010, while recent research suggests financial conflicts of interest among committee members have increased after an earlier decline, according to a systematic review published in the 10/29 JAMA Network Open. Researchers from Yale University and other institutions examined 146
FDA has issued final guidance recommending a comprehensive, risk-based approach to assuring the potency of cellular and gene therapy (CGT) products throughout development and commercial manufacturing, replacing its January 2011 guidance focused on potency testing. The guidance, Potency Assurance for Cellular and Gene Therapy Products, recommends that manufacturers integrate
FDA's anticipated proposal to restrict direct-to-consumer (DTC) prescription drug advertising could face significant statutory and First Amendment challenges, while changes in agency leadership raise questions about whether the administration's advertising enforcement campaign will maintain its momentum, attorneys said during a recent FDLI conference panel.
FDA's developing rare disease regulatory framework could make early patient engagement an essential part of drug development, rather than an activity primarily associated with advisory committee meetings and later stages of regulatory review, according to CBER director Karim Mikhail. Speaking at a 10/16 Reagan-Udall Foundation meeting,
FDA has released 33 additional Form FDA-483 inspection reports on 10/30, covering drug and biologic manufacturers, medical device companies, and human tissue establishments in the U.S. and overseas. The newly disclosed records include inspections of Baxter Healthcare, Catalent Maryland, Andelyn Biosciences, Charles River Laboratories, Autolus, AGC Biologics,