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.
A new FDA post discusses research by CDER statisticians who developed innovative and more efficient ways to evaluate transdermal and topical delivery ...
Federal Register notice: FDA makes available a final guidance entitled Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment.
Federal Register notice: FDA makes available a final guidance entitled Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneum...
BIO says an FDA draft guidance on interpreting gene therapy product sameness is helpful and asks that the agency state that the draft does not cover g...