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The European Medicines Agency is planning to develop an EU portal and database as a single entry point for clinical trial data submissions by May 2016. Read More
The U.S. Food and Drug Administration has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More
The FDA on Tuesday issued final guidance clarifying when large drug compounding facilities must register with the agency, making only a few changes to a draft version released in February. Read More
A House Energy and Commerce Committee report on cybersecurity breaches at HHS blames the FDA for not acting forcefully enough to prevent a known web vulnerability that has been a security concern for the past decade. Read More
Drugmakers and patient groups are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough. Read More