[ Price : $8.95]
FDA warns Auckland, New Zealand-based Adept Medical about Quality System and other violations in its production of ventilation tub...[ Price : $8.95]
FDA warns Milan, Italy-based Eurosirel about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA publishes a draft guidance with recommendations to oncologic drug sponsors about measuring ovarian toxicity in relevant clinic...[ Price : $8.95]
The DC federal court agrees with FDA that a suit against the agency over identifying an attorney in a regulated company on a form ...[ Price : $8.95]
FDA accepts for review a Satsuma Pharmaceuticals NDA resubmission for STS101 (dihydroergotamine nasal powder) for the acute treatm...[ Price : $8.95]
Based on just-reported Phase 3 trial data, Axsome Therapeutics says it will submit an NDA for on AXS-12 (reboxetine) and its use i...[ Price : $8.95]
FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To S...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at Limerick, Ireland-based Regeneron Ireland Designated Act...