The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in ...
The trend for the timing of initial marketing authorization applications (MAAs) to be less predictable is slowly reversing ...
The top generic drug regulator at the US Food and Drug Administration (FDA) on Wednesday touted the drop in refuse-to-receive ...
The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for ...
The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions ...
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 ...
The new member-exclusive RAPS Journal of Regulatory Affairs, a bimonthly, peer-reviewed publication building on the success ...
Office of Prescription Drug Promotion (OPDP) has stepped up its enforcement efforts regarding prescription drug promotion, ...
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