Qiagen Sciences recalls the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display.
Federal Register notice: FDA withdraws 27 ANDAs from multiple applicants after the application holders told the agency that the drug products were no ...
FDA warns Canadas Les Produits Chimiques about deviations from CGMP regulations for active pharmaceutical ingredients.
Two medical device stakeholders urge FDA not to lengthen the review time for Q-Sub submission issue requests filed more than 30 days after a marketing...
FDA releases an FDA-483 with eight observations from an inspection at South Koreas Celltrion.
FDA accepts for review a Glenmark Pharmaceuticals NDA for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), an investiga...
CBER says a Web site is promoting unapproved HIV tests for sale in the U.S.
FDA releases its latest batch of Warning Letters that includes one medical product company Les Produits Chimiques B.G.R.