An FDA draft guidance on reporting manufacturing changes in cellular and genetic therapy (CGT) products puts too much emphasis on clinical trials and neglects the benefits and efficacy of bridging…

At first, the idea of repurposing a drug seems so logical. A reasonable person could be forgiven for thinking this is already common practice. Since safety and efficacy have been…

In this edition of Quick Notes, we review recent FDA drug approvals of Zepbound for weight loss, Fruzaqla for colorectal cancer, Cosentyx for hidradenitis suppurativa, Keytruda for biliary cancer, and…

After 19 pilot programs conducted with medical device companies, regulators and patient communities, CDRH’s revised CAPA process is showing a 60 percent closure rate in under 60 days and a…

As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an…

The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections…

Quality agreements between companies and third-party vendors should explicitly define key manufacturing roles and responsibilities and establish expectations for communication, such as by providing key contacts for both entities, says…

Public health officials, patient advocacy groups and health scholars have filed amicus briefs supporting the U.S. government as it fights a lawsuit from AstraZeneca claiming the Inflation Reduction Act’s (IRA)drug…

Over the past week, the FDA issued final guidance on real-time oncology review and cosmetic product facility registration and product listing. Source: Drug Industry Daily