FDA

Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

Today, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., April…

FDA Roundup: March 18, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On March 18, the FDA added the…

FDA, Reagan-Udall Foundation to Hold Important Public Workshop to Discuss Naloxone Access

The U.S. Food and Drug Administration will host a virtual public workshop on Mar. 29, to discuss critical questions around access to naloxone, a drug…

FDA Roundup: March 15, 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 announcing the availability…

FDA Approves First Generic of Symbicort to Treat Asthma and COPD

Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two…

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

Today, the U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef…

FDA Roundup: March 4, 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:…

FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

Today, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance…

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

Today, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently…

FDA Roundup: February 25, 2022

February 25, 2022

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Feb. 24, the FDA issued an…