FDA

FDA Roundup: April 8, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On April 7, the FDA authorized an…

Joint Statement from CMS Administrator Chiquita Brooks-LaSure and FDA Commissioner Robert M. Califf, M.D., on Ensuring Access to Safe and Effective Treatments

Ensuring the availability of innovative interventions for people is a shared priority for both the Centers for Medicare & Medicaid Services (CMS) and the U.S….

FDA Roundup: April 5, 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 announced sotrovimab is no…

FDA Roundup: April 1, 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 published the FDA Voices:…

Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and…

FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs

Today, the U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President’s fiscal year (FY)…

Federal judge enters consent decree against New Jersey raw animal food manufacturer

The U.S. Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed…

FDA Roundup: March 25, 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 is issuing a 30-day…

FDA Roundup: March 22, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On March 22, the FDA published a…

FDA Statement on Medical Device User Fee Amendments (MDUFA)

The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user…