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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. In major news this week, FDA is facing two high-profile departures, beginning with the resignation of FDA Commissioner Marty Makary, who stepped down on Tuesday after just one year in office.

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. Multiple outlets reported that FDA Commissioner Marty Makary is being pushed out at FDA, though it is unclear how or when the departure will take place.

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 appointment of Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER) and the House Appropriations committee advanced a bill to fund FDA in FY 2027.

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. The US Food and Drug Administration (FDA) made several announcements related to its new drug voucher program, highlighted efforts to reduce animal testing, and more.

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 issued new guidance on organic impurities in antibiotics and sent a letter to combination product makers alerting them to potential nitrosamine impurities in products with a drug constituent.

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 presented its proposed budget to Congress, the agency rejected a petition for a partial 510(k) exemption for certain software products, and former top CDRH officials launched a venture capital firm.

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 Commissioner Marty Makary reflected on his first year, FDA is reportedly looking to drop peptide manufacturing restrictions, and more.

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.