The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for ...

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 Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...

Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance ...

The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the ...

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.

<i>Regulatory Focus</i> is the only source of timely, quality news and information fully dedicated to daily online coverage of the global regulation of healthcare products. An experienced team of ...