RAPS

Frequent communication with industry and relying on assessments by other regulators have enabled the rapid scale-up of COVID-19 vaccines and...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US U.S. FDA advisers to vote on J&J...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US US would seek global approach to...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation...

The US Food and Drug Administration (FDA) has finalized its guidance on developing drugs to treat chronic hepatitis B virus (HBV) infection. The...

The US Food and Drug Administration (FDA) has presented a framework to update the composition of COVID-19 vaccines based on new strains. During...

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s...

During an extraordinary meeting of its Oncologic Drugs Advisory Committee (ODAC) on Thursday, the US Food and Drug Administration (FDA) raised...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump says not pressing US government...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation,...