Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during ...
CDSCO proposed the system in January 2026 as part of an amendment to the New Drugs and Clinical Trial Rules, 2019. The system ...
Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline, but a speaker ...
The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...
The US Food and Drug Administration (FDA) has called on its Pharmacy Compounding Advisory Committee to discuss whether a ...
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in ...
The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions ...
The US Food and Drug Administration (FDA) has issued a warning letter to Purolea Cosmetics Lab for several violations of Good ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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