Former FDA principal deputy commissioner Rachel Sherman joins Aptinyxs board of directors.
FDA summarizes labeling changes to Gileads Solvadi and Harvoni to add pediatric dosage forms.
Researchers say early FDA drug safety communications on Pfizers Chantix led to reduced prescribing in the VA health system, leading to an estimated 45...
An new study suggests that FDAs 2013 move to a consumer-friendly adverse event reporting form has contributed positively to both the quality and quant...
Federal Register notice: FDA submits to OMB an information collection extension for Abbreviated New Animal Drug Applications.
Canadian health professor Matthew Herder says FDAs power to withdraw a drug if its manufacturer fails to produce useful required post-approval studies...
Federal Register notice: FDA releases final guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Pre...
FDA warns Costa Ricas Polimeros y Servicios about CGMP and other violations in its manufacturing of OTC drugs.