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Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.

The top generic drug regulator at the US Food and Drug Administration (FDA) on Wednesday touted the drop in refuse-to-receive (RTR) decisions his office issued for abbreviated new drug applications (ANDAs) in FY 2025 as a significant achievement for the agency.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This Week, FDA issued new guidance on organic impurities in antibiotics and sent a letter to combination product makers alerting them to potential nitrosamine impurities in products with a drug constituent.

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, while other topics, such as drug master files (DMFs) and forfeiture determinations are still being discussed.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.

The US Food and Drug Administration (FDA) has finalized guidance for manufacturers on using physicochemical and structural (Q3) characterization studies to establish bioequivalence in abbreviated new drug applications (ANDAs) for topical medications.

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the move would modernize adverse event reporting systems and provide more transparency.

The European Medicines Agency (EMA) has published a document detailing its methodology for monitoring potential vulnerabilities in the medicine supply chains. The agency said its new framework is intended to prevent potential shortages of drugs considered especially important on the Union List of Critical Medicines (ULCM).