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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.

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 This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.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

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

The Center for Science in the Public Interest has published a set of recommendations in JAMA they say would help improve transparency at the US Food and Drug Administration (FDA).

The US Government Accountability Office (GAO) says that the US Food and Drug Administration (FDA) should issue a timeline for finalizing a guidance on handling potential financial conflicts of interest for members of its advisory committees. The agency said the move would provide the public with greater transparency and assurance that it is taking significant mitigating steps to prevent conflicts of interest in regulatory decision-making.

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

Top European officials said they are optimistic that amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will be enacted quickly, but the amendments must also comply with legislative requirements, which will take several months.

The Philippine Food and Drug Administration (FDA) is holding a consultation into plans to update and standardize the contents of the License to Operate (LTO) for pharmaceutical establishments.

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

There have been a handful of artificial intelligence (AI)-enabled medical devices approved by the US Food and Drug Administration (FDA) over the last decade, and those that were have been limited to a few clinical areas, according to recent research published in JAMA Network Open.

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 said it wants to gather public feedback on the Commissioner's National Priority Voucher program, amid questions about the validity of claims about its speed by FDA Commissioner Marty Makaray.

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

The European Medicines Agency (EMA) has introduced three features to improve its PRIME scheme for supporting the development of medicines targeting unmet medical needs.

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