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 ...

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 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 ...

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) ...

In recalls the FDA describes as the most serious type, Inari Medical is updating its directions for use of its ClotTriever XL catheter and Medline is warning against use of the syringes included in ...

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 ...

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

The FDA has finalized guidance on the Voluntary Malfunction Summary Reporting (VMSR) program that allows manufacturers to submit medical device reports (MDRs) for certain low-risk devices to the ...

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.