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COVID-19 Breathalyzer Diagnostic
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples
PR-M04-22-09
Regulatory
FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review
PR-M03-22-03
FDA
FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System
PR-M07-20-NI-016
Coronavirus
FDA Issues Statement on Ensuring Safety of Foreign Products During Coronavirus Outbreak
PR-M02-20-NI-035
Drug Pricing
FDA CDER Head Castigates Pharma Industry
PAO-M09-19-NI-017
FDA
Statement Alerting Patients and Health Care Professionals of NDMA Found in Samples of Ranitidine
PR-M09-19-NI-043
FDA Statement
Statement on Agency’s Efforts to Increase Transparency in Medical Device Reporting
PR-M06-19-NI-048
FDA
Gluten-Free Food Labeling: Important Information for Those with Celiac Disease
PR-M05-19-NI-029
FDA Statement
Statement from FDA on New Efforts to Protect Women's Health and Help to Ensure the Safety of Breast Implants
PR-M05-19-NI-016
FDA Statement
Statement from the FDA's Center for Devices and Radiological Health on Reducing Risks Associated with Surgical Staplers
PR-M04-19-NI-074
FDA Statement
FDA Statement from Deputy Commissioner On New Steps to Protect Consumers from Unlawful Ingredients in Dietary Supplements
PR-M04-19-NI-059
Shortage
FDA Efforts to Mitigate Temporary Shortage of Pediatric Breathing Tubes Due to Recent Closure of Illinois Sterilization Facility
PR-M04-19-NI-049
FDA Statement
FDA Statement on New Opioid Analgesic Labeling Changes
PR-M04-19-NI-042
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
PR-M04-19-NI-038
FDA
Statement from FDA on the Agency's List of Known Nitrosamine-free Valsartan and ARB Class Medicines
PR-M04-19-NI-035
Stem Cells
Statement by FDA on Efforts to Stop Stem Cell Clinics and Manufacturers from Marketing Unapproved Products and Advance Legitimate Development
PR-M04-19-NI-031
Compounded Drugs
Statement from FDA on New 2019 Efforts to Improve the Quality of Compounded Drugs
PR-M04-19-NI-030
FDA
Statement by FDA on Expanded Patient Access Looking Forward
PR-M04-19-NI-009
FDA
U.S. FDA Commissioner Gottlieb Appears Before the Senate Appropriations Committee
PAO-M04-19-NI-002
FDA Statement
Statement from FDA Commissioner On Preventing Medical Device shortages and Effective Sterilization Amid Contract Sterilization Facility Shutdown
PR-M03-19-NI-084
FDA
FDA Announces Modernization Strategies for Clinical Trials of Precision Medicines
PAO-M03-19-NI-025
Biosimilars
Statement from FDA Commissioner on Naming of Biological Medicines to Balance Competition and Safety for Patients Receiving These Products
PR-M03-19-NI-030
Drug Recall
FDA Provides Update on its Ongoing Investigation into ARB Drug Products and Losartan Product Recall
PR-M03-19-NI-001
FDA Statement
Statement on the FDA's Modern Approach to Advanced Pharmaceutical Manufacturing
PR-M02-19-NI-064
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