Stakeholders question an FDA proposal to conduct research into the relationship between disease awareness and product-specific television ads.
FDA approves a new indication for Medtronics Pipeline Flex embolization device.
The International Conference on Harmonization outlines roles an informal discussion group on generic drugs will play to explore harmonization of scien...
FDA updates medical device reports on the risk of breast implant associated-anaplastic large cell lymphoma associated with all forms of breast implant...
CDER director Janet Woodcock says the Center will implement a new multidisciplinary team NDA and BLA regulatory approval program in this fiscal year.
Federal Register notice: FDA announces a 2/26 Oncologic Drugs Advisory Committee meeting to review a Karyopharm Therapeutics NDA for treating multiple...
Federal Register notice: FDA makes available a draft guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment.
FDA issues a final guidance entitled Opioid Use Disorder (OUD): Developing Buprenorphine Depot Products for Treatment.