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 ...
The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
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) ...
Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising ...
The European Commission has published an analysis detailing the benefits of enacting the European Biotech Act, which was ...
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies ...
The US Food and Drug Administration (FDA) recently issued warning letters to drugmakers in Japan and the US, as well as a ...
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 ...
The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review ...
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