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 ...

The FDA has issued a request for information (RFI) for advancing model-informed drug development (MIDD) to assist CDER and CBER in identifying and prioritizing potential focus areas for future policy ...

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 ...

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 ...

Including quantitative descriptions and information about serious adverse effects in direct-to-consumer (DTC) ads for a fictional Alzheimer’s medication heightened patients’ apprehensions about the ...

The FDA has updated its technical guide for sponsors of NDAs or BLAs on submitting clinical trial datasets to CDER’s bioresearch monitoring (BIMO) program.

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 ...

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 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 ...

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 FDA fired off Warning Letters to four companies — two in China and two in the U.S. — for marketing CPAP cleaning and sanitizing devices without clearance or approval.