CDER researchers say it may be possible to streamline clinical trials for drugs to treat schizophrenia by cutting the trial length and cutting the num...
Federal Register notice: FDA extends the comment period on a 7/15 notice about a draft guidance #61 entitled Special Considerations, Incentives, and P...
FDA releases its latest batch of Warning Letters that includes one medical product company Nartex Laboratorios Homeopaticos.
Pfizer and BioNTech report data from an interim efficacy analysis showing that their Covid-19 vaccine is more than 90% effective in preventing the vir...
FDAs Peripheral and Central Nervous System Drugs Advisory Committee votes not to recommend approval of Biogens Alzheimers drug aducanumab.
President-elect Joe Bidens transition team announces the formation of the Transition Covid-19 Advisory Board, which is co-chaired by former FDA commis...
CDER posts a report on Global Participation in Clinical Trials: 2015-2019 that summarizes the Centers Drug Trials Snapshot program by illustrating the...
Federal Register notice: FDA releases a final guidance describing insanitary conditions at drug compounding facilities.