FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies ...
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. In major ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The US Food and Drug Administration (FDA) has issued warning letters to two researchers for failing to meet good clinical practice (GCP) requirements and for not complying with their own trial ...
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to ...
Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising ...
Industry groups and legal experts want the US Food and Drug Administration (FDA) to make significant revisions to a proposed guidance on how pharmaceutical manufacturers should address Form 483 ...
The Pharmaceutical Research and Manufacturers of America (PhRMA) said the US Food and Drug Administration’s (FDA) recent ...
Join a RAPS San Francisco networking and recruitment series across multiple in-person events. Meet regulatory professionals, connect with chapter leaders, and learn about ambassador and leadership ...
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