The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for ...
The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Industry groups are asking the US Food and Drug Administration (FDA) for greater transparency into its Commissioner's National Priority Voucher (CNPV) pilot, including how the agency intends to ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance ...
India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.
The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the ...
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