Federal Register notice: FDA sends to OMB an information collection extension entitled Export Notification and Recordkeeping Requirements.
Federal Register notice: FDA classifies the autofluorescence detection device for general surgery and dermatological use into Class 2 (special control...
FDA issues a four-item Form FDA-483 to Wedgewood Connect after an inspection of its San Jose, CA drug manufacturing facility cited significant GMP vio...
Federal Register notice: FDA sends to OMB an information collection extension entitled Public Health Service (PHS) Guideline on Infectious Disease Iss...
CDER's Office of Prescription Drug Promotion seeks comments on a research proposal to understand the Tradeoff Analysis of Prescription Drug Product Cl...
Axsome Therapeutics expects to receive a complete response letter on its NDA for migraine drug AXS-07 (meloxicam-rizatriptan) due to FDA-identified ch...
Eleven defendants, including the founders of several lab companies, plead guilty in a $300 million scheme to pay kickbacks to induce medical professio...
FDA expands the approval of Gilead Sciences Veklury (remdesivir) to include treating Covid-19 pediatric patients 28 days of age and older weighing at ...