The FDA issued a complete response letter (CRL) for foscarbidopa/foslevodopa (ABBV-951) based on observations from an inspection at one of AbbVie’s third-party manufacturing facilities, the company announced yesterday. Source: Drug…
In a reversal of the previous court’s decision, the US Court of Appeals for the Federal Circuit gave Amarin a win in its fight over Hikma’s generic version of Amarin’s…
The seven-year effort to modernize FDA’s New Drugs Regulatory Program (NDRP) has paid off, with improvements in assessing drug approval applications, monitoring drug safety, operational efficiency and recruiting and retaining…
Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers. Source: Drug Industry Daily
The FDA is seeking comments on both its information technology (IT) and its customer experience strategies to guide its work and its allocation of budget and resources in the coming…
Novo Nordisk announced plans to invest $4.1 billion to build a fill and finishing manufacturing facility in North Carolina and grow its ability to produce current and future injectable treatments…
With FDA’s new regulation of laboratory developed tests (LDT) that becomes effective July 5, the agency has issued a final guidance intended to help small entities comply. Source: Drug Industry…
The United States Pharmacopeia (USP) and the FDA are working together to promote opportunities for sponsors to develop new generic medications for off-patent drugs that currently lack an approved generic…
In this edition of Quick Notes, Akili snags approval for a video game-based ADHD treatment, Johnson & Johnson’s orthopedics unit wins FDA authorization for a partial knee replacement robotic-assist system,…
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…