Federal Register notice: FDA seeks an information collection extension on its guidance on emergency use authorizations.
Amarin says it will respond to a citizen petition asking for a synthetic omega-3 exclusion from dietary supplement structural requirements by demonstr...
Federal Register notice: FDA makes available a draft guidance entitled Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues....
Researchers call for reevaluation of the iPLEDGE isotretinoin program and exploration of new approaches to lower fetal exposure to the drug.
Pear Therapeutics says it filed a request for marketing authorization with FDA for its Somryst prescription digital therapeutic to treat chronic insom...
FDA warns Virginia Center for Reproductive Medicine about repeat deviations from regulations governing human cells, tissues, and cellular and tissue-b...
The Congressional Budget Office says several provisions in Sen. Alexanders Lower Health Care Costs Act would change FDA regulatory authority to speed ...
Two stakeholders suggest changes to an FDA draft guidance on medical device establishment inspection processes and standards.