FDA sends Griffo Botanicals (Petaluma, CA) a Warning Letter after reviewing the companys Web site and social media sites and determining that its herb...
The Government Accountability Office recommends five steps FDA should take to strengthen its oversight of safety in agency laboratories that work with...
Federal Register notice: FDA corrects a notice that published in the 9/21 Federal Register announcing the withdrawal of a final guidance entitled Inve...
The data intelligence consulting firm Govzilla posts information on how regulated companies should talk to FDA and listen when FDA talks.
FDA grants X4 Pharmaceuticals a Fast Track Designation for mavorixafor for treating adult patients with WHIM (Warts, Hypogammaglobulinemia Infections ...
FDA awards $16 million in six grants to help in developing treatments for rare diseases.
CDRHs Timothy Stenzel tells a virtual town hall that under an HHS ruling FDA is declining to review new EUA submissions for Covid LDT tests and those ...
FDA grants Y-mAbs Therapeutics an orphan drug designation and rare pediatric disease designation for its antibody nivatrotamab and its use in treating...