Regulatory Focus

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, the acting FDA commissioner wrote an op-ed promoting the agency’s efforts to incentivize domestic drug manufacturing, FDA announced new grants for using digital health technologies (DHT) for drug development, and it approved an over-the-counter combination of two popular pain drugs.

An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound treatment and inflammatory conditions – be added to the list of drugs eligible for bulk compounding, known as the 503A Bulks List.

Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the time of approval. Of those, the vast majority of study results were published in ClinicalTrials.gov or another publication, according to an article published Thursday in JAMA Network Open.

The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.

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

The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.

The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better standardized as they are added to Europe's new clinical trial database the European Database on Medical Devices (Eudamed).

The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act, including examples of exceptions to these requirements. While not specific to healthcare products, companies developing healthcare products with an AI system component may be subject to transparency rules.