Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) draft guidance on new approach ...
A Health Technology Assessment Regulation (HTAR) governance body has published guiding principles on data transparency.
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, ...
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 ...
Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements. TGA ...
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 ...
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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