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 ...

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 ...

A host of problems discovered through a July FDA inspection of Biocon Biologics’ Bengaluru, India facility has led to a ten observation Form 483 for the biopharmaceutical company, which produces ...

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 ...

The Association for Molecular Pathology (AMP) is taking legal measures to neutralize an FDA final rule that regulates laboratory-developed tests (LDT), filing a lawsuit in the US District Court for ...

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 ...

A once promising surgical robotics deal with Auris Health has ended in $1 billion in damages for Johnson & Johnson, with a Delaware judge ruling that the healthcare titan failed to honor its end of a ...

Glenmark Pharmaceuticals has agreed to pay $25 million to resolve its alleged liability under the False Claims Act (FCA) for conspiring to fix the price of pravastatin, the Department of Justice (DOJ) ...

Ophthalmology-focused biopharma EyePoint Pharmaceuticals received an FDA Warning Letter underscoring serious GMP violations at its Watertown, Mass., facility, mostly related to a one-time injection ...