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.
As the United States makes efforts to eradicate Covid-19 under a new president’s administration, the Food and Drug Administration is tasked with rebuilding the regulatory agency’s reputation with a new commissioner.
The U.S. Food and Drug Administration warned health care personnel not to make any changes to the dosing of Covid-19 vaccines and that doing so would place the public health at risk and undermine “the historic vaccination effort to protect the population.”
Moderna Inc.’s coronavirus vaccine mRNA-1273 became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration, welcome news to a nation with a staggering Covid-19 death toll of more than 307,000 lives lost.
A panel of outside advisers to the U.S. Food and Drug Administration overwhelmingly endorsed emergency use of Moderna Inc.’s coronavirus vaccine, virtually assuring a second option for protecting against Covid-19 for a pandemic-ravaged nation.
