We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More
The FDA’s Office of Prescription Drug Promotion warned a Valeant Pharmaceuticals subsidiary for failing to include risk information in promotional material for a cough suppressant. Read More