The FDA spells out how long it expects to take to review amendments to generic drug applications in a final guidance that reflects the agency’s commitments under the Generic Drug User Fee Amendments ...

Ensuring that data and records generated for medical products are secure, trustworthy and of high quality throughout the whole R&D process is a pivotal concern today, with data integrity violations ...

After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today.

After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today.

After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today.

The European Medicines Agency (EMA) and Europe’s Heads of Medicines Agencies (HMA) say large language models (LLMs) — a form of AI that generates text in response to prompts — may be used by medicines ...

This excerpt is from the management report titled “Using Real-World Evidence in Drug and Device Submissions,” based on a webinar from FDAnews, A WCG Company. The presenters were Kristin Zielinski ...

The FDA urges API and drug manufacturers to adopt a three-step mitigation strategy to prevent high levels of nitrosamine impurities, in a new revised guidance. The new guidance revises a final ...

Rare disease advocacy groups often use the phrase “rare is not rare” to drive home the point that although individual diseases and conditions might affect only a small number of people, together they ...

The FDA issued a Letter of Support to the Critical Path Institute’s Parkinson’s consortium to encourage the use of alpha-synuclein (α-syn) — a pathologic protein linked to several neurodegenerative ...

House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) has requested that the CEOs of three major pharmacy benefit managers (PBM) correct the record for statements made last ...

The FDA offers updated advice to medical device sponsors on how to use patient preference information (PPI) throughout the product lifecycle, in a new draft guidance.