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 released more details on its FY2024 budget request, Pfizer announced it is recalling millions of packages of a migraine drug over concerns about its packaging and FDA advisors back the approval of Pfizer’s COVID-19 drug Paxlovid.   FDA’s nearly 300-page FY 2024 budget ...

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 was a big news week for FDA watchers – we saw the release of the Biden administration’s FY 2024 budget request and FDA’s roadmap for how it will handle dozens of COVID-19 pandemic era guidances now that the COVID-19 public health emergency (PHE) is winding down.   In a Federal...

Updated 7 March 2023 to clarify what products FDA's guidance on potency assays for monoclonal antibodies applies to.   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, we learned that the agency is indeed moving forward with rulemaking to get diagnostics reform, a top official involved in the Aduhelm approval story is ...

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, we learned that FDA has filled two leadership roles at the agency, and that it will host an upcoming patient-focused drug development (PFDD) meeting focused on long COVID. It also announced the authorization of the first at-home test for COVID-19 and influenza.   On Friday...

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 Robert Califf called for reforming the agency’s advisory committee system, experts gave a thumbs up to potentially the first OTC opioid overdose drug and more.   Speaking at the Biopharma Congress meeting in Washington, DC, Califf said that the Food and ...

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, we watched FDA Commissioner Robert Califf testify before the new Congress for the first time and read about the use of artificial intelligence/machine learning (AI/ML) image analysis tools to characterize biotherapeutics.   On Wednesday, Califf and other top Biden administ...

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 gave its first quarterly update on its hiring goals under its prescription drug and biosimilar user fee programs. The agency also finalized guidance on quality considerations for cannabis and cannabis-derived drugs and said that a new regulatory pathway is needed for canna...

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, Ranking Member of the House Energy & Commerce Committee Frank Pallone (D-NJ) wrote to FDA Commissioner Robert Califf and Lawrence Tabak, acting director of the National Institutes of Health (NIH), urging greater enforcement of clinical trial results reporting in ClinicalTria...

Editor's note: This article has been updated to correct a link to the Federal Register. 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 two developments that could promote international regulatory harmonization and ease some burdens for regulated industry.   On Thursday, FDA said it had signed a mut...

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, we saw FDA grant accelerated approval to Eisai's Alzheimer’s disease drug Leqembi (lecanemab-irmb). The agency also moved to enable retail pharmacies to dispense mifepristone by revising the shared risk evaluation and mitigation strategy (REMS) for Mifeprex and g...

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, we’ve been watching as Congress advances an omnibus spending bill that would provide FDA with a $226 million increase in budget authority and institute reforms for the agency’s accelerated approvals program and cosmetics oversight.   In a 225-201 vote, the House passed the...

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 an upcoming meeting to consider whether the composition of primary COVID-19 vaccine doses should be updated given waning immunity and continued evolution of the virus. We also saw the approval of the first gene therapy to treat bladder cancer, new guidance on wha...