Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program ...
It isn’t always clear when to choose to verify or validate manufacturing processes. But experts from the US Food and Drug ...
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have proposed a parallel ...
The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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 US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for violations of current good manufacturing practices (CGMP) and for marketing ...
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