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.
The FDA plans to conduct two studies to gauge whether consumers and healthcare professionals have the capacity to detect and report deception prescription drug advertisements. Read More
The FDA refused to approve Cempra’s community-acquired bacterial pneumonia antibiotic Solithera, citing manufacturing and safety concerns in a complete response letter. Read More
The FDA has laid out a list of situations in which the agency would not enforce certain violations related to the compounding and repackaging of radiopharmaceuticals. Read More
Submissions of manufacturing establishment information (MEI) by manufacturers are about to be changed. A new FDA draft guidance has been published outlining the requirements and implementation regarding valid electronic submission of MEIs. Read More