[ Price : $8.95]
FDA denies a petition questioning Eugia Pharmas use of an ANDA for a generic Makena autoinjector.[ Price : $8.95]
Oncology Center of Excellence director Richard Pazdur and chief of medical oncology Julia Beaver call for changes in the developme...[ Price : $8.95]
FDA denies a Par Sterile Products petition saying it failed to raise valid scientific or regulatory issues and was submitted as a ...[ Price : $8.95]
FDA posts a draft guidance entitled Inspection of Injectable Products for Visible Particulates.[ Price : $8.95]
CDRH Office of Product Evaluation and Quality director William H. Maisel tells an industry conference that the agency is planning ...[ Price : $8.95]
FDA warns Lincolnwood, IL-based Dental Technologies about CGMP and QS regulation violations at its contract drug and medical devic...[ Price : $8.95]
FDA says fact sheets for the Janssen Covid-19 vaccine have been updated with a Contraindication for the vaccine in individuals wit...[ Price : $8.95]
FDA issues a draft guidance on the redesignation of the definition of device in the Federal Food, Drug, and Cosmetic Act and the a...