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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. Multiple outlets reported that FDA Commissioner Marty Makary is being pushed out at FDA, though it is unclear how or when the departure will take place.

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on chemistry, manufacturing, and controls (CMC) flexibilities for cell and gene therapy (CGT) products developed for biologics license applications (BLAs).

Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the RAPS Euro Convergence 2026 conference closing plenary; however, they cautioned that oversimplification could backfire and lead to more regulation down the road.

Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to consolidate 40 different application data sources across all centers at the Food and Drug Law Institute’s (FDLI) Annual Meeting on Thursday.

LISBON – Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical follow-up (PMCF) plan is realistic, according to experts who spoke at RAPS Euro Convergence 2026 on Thursday.

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

MedTech Europe has shared feedback on planned changes to the European Union’s medical device and diagnostic regulations, offering high-level support for the revisions while calling for tweaks to aspects of the proposals.

Marty Makary, the Commissioner of the US Food and Drug Administration (FDA), announced a new pilot program promising one-day inspections for low-risk facilities on Wednesday.

LISBON – A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the EU Medical Device Regulation (MDR) at the RAPS Euro Convergence 2026 conference on Wednesday.

The European Commission on Tuesday published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).

LISBON – Regulators will need to evolve as new technologies come to market, according to experts who spoke at the opening plenary session of RAPS Euro Convergence 2026. Major challenges include finding the right balance between safety and regulatory flexibility and determining an acceptable level of uncertainty.

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).