Use of Symbols in Labeling By Global Compliance Seminar (LinkedIn; Twitter) Food and Drug Administration; 21 CFR Parts 660, 801, and 809; [Docket No. FDA-2013-N-0125] June 15, 2016 The Food and Drug Administration (FDA or the Agency) issued the final rule below revising its medical
The United States Food and Drug Administration Electronic Medical Device Report (eMDR) Files Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files The FDA/CDRH staff has created a packet of files to assist in implementing software for generating the
FDA Warning Letter Violations of UDI Requirements Stat Medical Devices, Inc. 7/23/15 Department of Health and Human Services Public Health Service Food and Drug Administration Florida District 555 Winderley Place, Suite 200 Maitland, Florida 32751 Telephone: 407-475-4700 Fax: 407-475-4770 VIA UPS
FDA Warning Letter NDA 021876 DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use Dear Mr. Gervais: The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the Kim Kardashian Social
Agency recommends adding important safety information to product labels November 24, 2014 Release Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids.