FDA

FDA Considers New Approach to Improve Safe Disposal of Prescription Opioid Analgesics, Decrease Unnecessary Exposure to Unused Medication

Today, the U.S. Food and Drug Administration announced it is seeking public comment on a potential change that would require opioid analgesics used in outpatient…

FDA Roundup: April 19, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued its final rule…

FDA Warns of Risks Associated with Non-Invasive Prenatal Screening Tests

Today, the U.S. Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with…

FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

Today, the U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance…

FDA Roundup: April 15, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On April 14, the FDA issued an…

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath…

FDA Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances

Today, the U.S. Food and Drug Administration issued a final guidance, entitled “Compounding Animal Drugs from Bulk Drug Substances,” that will help protect animal health…

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials

Today, the U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and…

FDA Roundup: April 12, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On April 8, the FDA cleared Fitbit’s…

FDA and DEA Warn Online Pharmacies Illegally Selling Adderall to Consumers

The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration recently issued joint warning letters to operators of two websites illegally selling Schedule…