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The European Medicines Agency issued draft guidance last month on the manufacture of finished dosage forms, clarifying the information drugmakers should include in the quality section of the common technical document in a premarket application. Read More
The European Medicines Agency is seeking feedback on draft guidelines on conditional approval and accelerated assessment as it strives to fast track medicines for unmet medical needs. Read More
The U.S. House of Representatives approved the 21st Century Cures Act by a vote of 344 to 77 on July 10, moving focus to the Senate where efforts are underway to develop comparable legislation. Read More
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
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
Two FDA advisory panels will meet next month to discuss the effect of food intake on Purdue Pharma’s and Collegium Pharmaceuticals’ oxycodone drugs. Read More
A federal judge in New Jersey ordered a Hamilton, N.J., company charged with marketing unapproved and misbranded suppositories to destroy its stock and discontinue manufacturing the products. Read More