Federal Register notice: FDA announces a virtual public meeting entitled Generic Drug User Fee Amendments (GDUFA) of 2017.
Federal Register notice: FDA makes available guidance documents related to the Covid19 public health emergency.
FDA sends Curativa Bay (Clearwater, FL) a Warning Letter after reviewing the companys Web site and citing its Advanced Hypochlorous Skin Spray over mi...
FDA approves a Chiasma NDA for Mycapssa (octreotide) capsules for long-term maintenance treatment in certain acromegaly patients.
FDA posts a final guidance entitled Review and Update of Device Establishment Inspection Processes and Standards.
In observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 6.
Chengdu Ai Qin E-commerce Co. recalls its colored contact lenses after FDA notified the firm that they were distributed without agency clearance and m...
FDA sets a 7/21 virtual public meeting to hear comments on the GDUFA 3 reauthorization.