Former U.S. Food and Drug Administration Commissioner Robert Califf is one step closer to returning to his old office after the Senate Health, Education, Labor and Pensions Committee advanced his nomination in a 13–8 bipartisan vote.

The U.S. Food and Drug Administration added another warning to the regulatory agency’s fact sheet for Johnson & Johnson’s COVID-19 vaccine. In other news, as the Omicron variant rips through the United States, top health officials have noted that the variant is so contagious that if you come into contact with it, you are likely to catch it.

President Joe Biden on November 12 said he would nominate Robert Califf for a second stint as commissioner of the U.S. Food and Drug Administration, and urged the Senate to swiftly confirm him.

Acting U.S. Food and Drug Administration Commissioner Janet Woodcock’s days as interim head of the regulatory agency are numbered due to federal regulations. Not only does President Biden have to appoint a new FDA commissioner, he will also need to tap a new head of the National Institutes of Health (NIH) following the retirement announcement of longtime director Francis S. Collins, M.D., Ph.D.

U.S. President Joe Biden’s administration ruled out nominating Janet Woodcock as the permanent head of the Food and Drug Administration, Bloomberg News reported on Aug. 19, citing people familiar with the matter.

Stephen Hahn, the Commissioner of the U.S. Food and Drug Administration under former President Donald Trump, took on a new role as chief medical officer of a new health security initiative launched by Flagship Pioneering, a life sciences venture firm that incubates and curates biopharma companies.

Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a Q&A session with the Alliance for a Stronger FDA..

Six former FDA commissioners – Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney and Andrew von Escehenbach – signed a joint letter urging the U.S. president to nominate a permanent commissioner soon.

The U.S. Food and Drug Administration issued new guidance for vaccine makers as the regulatory agency is preparing for the possibility of needing to approve Covid-19 booster shots against variants of the SARS-CoV-2 virus.

Drugmakers should test any Covid-19 vaccines that have been retooled to combat new variants of the coronavirus in clinical trials designed to track the immune response of hundreds of subjects, which could take months, U.S. regulators said on Feb. 22.