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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA said it wants to gather public feedback on the Commissioner's National Priority Voucher program, amid questions about the validity of claims about its speed by FDA Commissioner Marty Makaray.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA announced the head of its biologics center is leaving the agency for the second time, the CDC's vaccine panel may be abandoning a plan to stop recommending COVID-19 mRNA vaccines, and a senator plans to investigate FDA's oversight of rare disease therapies.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. An FDA official criticized a rare disease drug sponsor, state representatives met with the agency to import cheaper drugs, and regulators warned a slew of telehealth companies for marketing compounded GLP-1 drugs.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA reportedly offered drug reviewers bonuses to speed regulatory decisions, the FDA commissioner defended the head of the biologics center, and a second product has been approved under the commissioner's new voucher program.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, top FDA officials announced that the agency would require only a single pivotal trial for most drugs, the agency reversed course and said it would review Moderna's mRNA influenza vaccine, and FDA Commissioner Marty Makary said that most drugs should be available over-the-counter (OTC).

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, Moderna announced FDA has refused to file its application for a new influenza vaccine – reportedly at the direction biologics head Vinay Prasad – and a former top FDA official has left the agency to work for the device industry group AdvaMed.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week FDA's new quality management system requirements took effect, FDA's PreCheck program opened for submissions, and an internal meeting was held to ease concerns about the Commissioner's National Priority Voucher program.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA's device center released its annual report for 2025, touting a record number of novel devices authorized last year, and some legislation affecting FDA could be included in a government funding deal.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week HHS ended research using aborted human fetal tissue and withdrew the US from the World Health Organization (WHO), and FDA published its 15th annual novel drugs report.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA officials and industry raised concerns about a drug review voucher program, Republican lawmakers called for restricting the use of mifepristone, and HHS reportedly removed a webpage with information on bogus autism treatments.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA updated two guidances aimed at reducing oversight of digital health products and published meeting minutes from its user fee negotiations.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA staffers raised concerns about the potential politicization of the commissioner's new drug voucher program, FDA said it doesn't plan on adding a boxed warning to COVID-19 vaccines, and the agency released details about proposals for the next generic drug user fee program.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, anti-abortion groups called for FDA Commissioner Marty Makary's resignation after reports he was slow walking a safety review of mifepristone, the agency is investigating potential COVID-19 vaccine-related deaths across age groups, and reviewing respiratory syncytial virus (RSV) vaccines.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, the FDA Commissioner Marty Makary announced the agency will shift its evidence standards for drugs to require a single pivotal trial – rather than two studies – for drugs by default.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, more reporting delves into a potential rift between the heads of HHS and FDA, ethical questions are being raised about the commissioner's new drug voucher program, and GOP attorneys are suing FDA for approving a generic abortion drug.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA's drug center is left without a leader after its director resigned over the weekend, the agency added six new drugs to its Commissioner's National Priority Voucher (CNPV) pilot, and the agency issued warning letters to a slew of online companies for illegally marketing unapproved botulinum toxin products online.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA announced it is revamping and simplifying its policies for biosimilars, there are reports of a staff shakeup at the agency's Office of the Chief Medical Officer, and news of a potential end to the ongoing government shutdown.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week, FDA published two guidance documents despite the ongoing government shutdown, some FDA staff reported payroll issues, and the agency is reportedly considering another overhaul of its inspection program.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we're reading from around the web. This week lawmakers are working to pass a potential 'minibus” budget bill to fund FDA and HHS admitted to accidentally laying off more staff than it meant to amid the ongoing government shutdown.