Apotex Health seeks to raise up to C$1.2 billion, potentially reviving Toronto IPO market ( Reuters) Is European ‘Reliability ...
The US Food and Drug Administration (FDA) has proposed guidance to reduce the need for animal testing in the development of ...
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 ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
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 ...
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 International Council on Harmonisation (ICH) announced the adoption of its M15 guideline, which aims to harmonize general principles and best practices for utilizing model-informed drug ...
The US Food and Drug Administration (FDA) recently issued warning letters to drugmakers in Japan and the US, as well as a ...
This course introduces the fundamentals of China’s medical device regulations and registration requirements. Navigating China’s regulatory market can be challenging, particularly when authorities ...
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 ...
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