Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
It isn’t always clear when to choose to verify or validate manufacturing processes. But experts from the US Food and Drug ...
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.
The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...
The new member-exclusive RAPS Journal of Regulatory Affairs, a bimonthly, peer-reviewed publication building on the success ...
The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for ...
The trend for the timing of initial marketing authorization applications (MAAs) to be less predictable is slowly reversing ...
The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in ...
The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...
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