COVID-19 Breathalyzer Diagnostic
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
U.S. Food & Drug Administration
PR-M04-22-09Apr 14, 2022
Regulatory
FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review
U.S. Food & Drug Administration
PR-M03-22-03Mar 07, 2022
FDA
FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System
U.S. Food & Drug Administration
PR-M07-20-NI-016Jul 13, 2020
Coronavirus
FDA Issues Statement on Ensuring Safety of Foreign Products During Coronavirus Outbreak
Nice Insight
PR-M02-20-NI-035Feb 25, 2020
Drug Pricing
FDA CDER Head Castigates Pharma Industry
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-M09-19-NI-017Sep 20, 2019
FDA
Statement Alerting Patients and Health Care Professionals of NDMA Found in Samples of Ranitidine
U.S. Food & Drug Administration
PR-M09-19-NI-043Sep 18, 2019
FDA Statement
Statement on Agency’s Efforts to Increase Transparency in Medical Device Reporting
Nice Insight
PR-M06-19-NI-048Jun 26, 2019
FDA
Gluten-Free Food Labeling: Important Information for Those with Celiac Disease
U.S. Food & Drug Administration
PR-M05-19-NI-029May 09, 2019
FDA Statement
Statement from FDA on New Efforts to Protect Women's Health and Help to Ensure the Safety of Breast Implants
U.S. Food & Drug Administration
PR-M05-19-NI-016May 06, 2019
FDA Statement
Statement from the FDA's Center for Devices and Radiological Health on Reducing Risks Associated with Surgical Staplers
U.S. Food & Drug Administration
PR-M04-19-NI-074Apr 24, 2019
FDA Statement
FDA Statement from Deputy Commissioner On New Steps to Protect Consumers from Unlawful Ingredients in Dietary Supplements
U.S. Food & Drug Administration
PR-M04-19-NI-059Apr 18, 2019
Shortage
FDA Efforts to Mitigate Temporary Shortage of Pediatric Breathing Tubes Due to Recent Closure of Illinois Sterilization Facility
U.S. Food & Drug Administration
PR-M04-19-NI-049Apr 16, 2019
FDA Statement
FDA Statement on New Opioid Analgesic Labeling Changes
U.S. Food & Drug Administration
PR-M04-19-NI-042Apr 12, 2019
FDA Warning
FDA Warns About Risks of Using Home Use Test Strips that are Pre-owned or Not Authorized for Sale in U.S., Including Those for Glucose, Warfarin
U.S. Food & Drug Administration
PR-M04-19-NI-038Apr 11, 2019
FDA
Statement from FDA on the Agency's List of Known Nitrosamine-free Valsartan and ARB Class Medicines
U.S. Food & Drug Administration
PR-M04-19-NI-035Apr 10, 2019
Stem Cells
Statement by FDA on Efforts to Stop Stem Cell Clinics and Manufacturers from Marketing Unapproved Products and Advance Legitimate Development
U.S. Food & Drug Administration
PR-M04-19-NI-031Apr 09, 2019
Compounded Drugs
Statement from FDA on New 2019 Efforts to Improve the Quality of Compounded Drugs
U.S. Food & Drug Administration
PR-M04-19-NI-030Apr 09, 2019
FDA
Statement by FDA on Expanded Patient Access Looking Forward
U.S. Food & Drug Administration
PR-M04-19-NI-009Apr 03, 2019
FDA
U.S. FDA Commissioner Gottlieb Appears Before the Senate Appropriations Committee
Emilie Branch
Pharma's Almanac
PAO-M04-19-NI-002Apr 02, 2019
FDA Statement
Statement from FDA Commissioner On Preventing Medical Device shortages and Effective Sterilization Amid Contract Sterilization Facility Shutdown
U.S. Food & Drug Administration
PR-M03-19-NI-084Mar 29, 2019