Regulatory Focus™

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent draft guidance on the development of a plausible mechanism framework for individualized therapies to treat rare diseases.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new approach methodology (NAM) using virtual control groups (VCG) in dose range finding studies that reduce the need for concurrent control groups that use animals.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Medicines Agency (EMA) has finalized a document with recommendations on using the European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) when submitting premarket applications that include real-world data.

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

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 This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

The US Food and Drug Administration (FDA) has finalized guidance on incorporating patient preference information (PPI) for assessing the benefit-risk profile of certain medical devices throughout the total product life cycle.

The US Food and Drug Administration (FDA) has warned an oncology drug company for repeatedly overstating the efficacy of its drug in advertisements while failing to adequately disclose the associated risks. The agency also issued several warning letters to companies for violations of current good manufacturing practices (CGMP) and for marketing products for non-approved indications.

The Pharmaceutical Research and Manufacturers of America (PhRMA) has stated that the ICH M4Q(R2) involves a significant restructuring of the quality section of the Common Technical Document (CTD), bringing major changes for both the industry and regulators. As such, ICH and regulatory authorities should promote global synchronization of the guideline’s implementation to reduce the need for maintaining dual dossier structures.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.