Federal Register notice: FDA sends to OMB an information collection revision entitled Current Good Manufacturing Practice in Manufacturing, Packaging,...
FDA posts a 3/5 FDA 483 citing a Dr. Reddys Laboratories inspection at a Telangana, India active pharmaceutical ingredient (API) facility last month.
Federal Register notice: FDA sends to OMB an information collection extension for Certification of Identity; Form FDA 3975.
FDA posts a guidance on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (Covid-19) Public Health Emergency (Revised)....
FDA grants Becton, Dickinson and BioGX an emergency use authorization for a new diagnostic test that will enable hospitals to screen for Covid-19 on s...
Federal Register notice: FDA submits to OMB an information collection revision for Special Protocol Assessments.
FDA posts a 15-item FDA 483 issued 2/25 to Shilpa Medicare following an inspection of the firms Telangana, India drug manufacturing facility.
Federal Register notice: FDA proposes to reclassify nucleic acid-based hepatitis C virus ribonucleic acid devices intended for the qualitative or quan...