Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker's plans to seek approval for a nail fungus treatment.
OraSure Technologies on Tuesday announced that the Food and Drug Administration's Blood Products Advisory Committee recommended that the OraQuick In-Home HIV test be made available without a prescription.
The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.
A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."
Watson has announced its intention to acquire Actavis, the company said. Following news reports that the U.S.-based generic drug maker would acquire Switzerland-based Actavis, Watson announced that it would buy the latter for $5.6 billion.
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.