An experimental kidney cancer drug made by Pfizer didn't extend the time in which patients survived without their disease worsening when compared with a competing drug, according to results of a late-stage clinical trial released Wednesday.
Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.
The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.
A 30% rise in attendance at the Armada Specialty Pharmacy Summit is nothing to brush off — it's as clear an indication as any that specialty pharmacy is growing and probably poised for more growth in the near future, thanks in particular to the aging population and consequential rise in the number of people living with difficult-to-treat medical conditions.
The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.