Some 18 members of Congress ask FDA 19 questions about Covid-19 vaccine safety in children under age 5.
University of Kentucky researchers say FDA should consider moving to an alternate approach to monitoring drug quality rather than relying on current g...
FDA delays making a decision on Novavaxs Covid-19 vaccine emergency use authorization request after the company submitted last minute manufacturing da...
A bipartisan group of six senators calls on the U.S. Patent and Trademark Office to change its policies and procedures to eliminate so-called patent t...
FDA orders some Propecia labeling changes sought in a 2017 petition and denies most of the other changes sought.
The U.S. House of Representatives votes 392 to 28 to pass the Food and Drug Amendments of 2022), which would reauthorize FDA user fee programs for pre...
FDA sets a Class 1 designation on a recall of GE Healthcares ventilator batteries used in certain Carescape R860 Ventilators.
Federal Register notices: FDA renews the charters for four advisory committees for an additional two years.