FDA warns Hanover, PA-based MD Pharmaceutical Supply about CGMP deviations in its drug repackaging and relabeling operations.
FDA warns The Woodlands, TX-based RoyalVibe Health about manufacturing, marketing, and distributing unapproved medical devices that are misbranded and...
FDA warns Sagent Pharmaceuticals about issues found in an inspection at its Plattsburg, NY-based sterile drug products manufacturing facility.
Bluebird Bio says it is working to resume enrollment and treatment of patients ages 2-17 in a lovo-cel sickle cell clinical trial after FDA lifts a pa...
FDA warns DuPont Nutrition USA about CGMP deviations in its manufacturing of the widely-used drug excipient Avicel.
FDA publishes an International Council for Harmonization guideline on a clinical electronic structured protocol.
Attorney Heidi Gertner explains how FDA is pushing for a voluntary Rx to OTC switch of naloxone drug products.
FDA publishes a guidance recommending that applicants change the labeling for antihypertensives to include standard language on the cardiovascular ben...
