FDA releases the FDA-483 with three observations from an inspection at East Marietta Drug Company.
FDA denies most requests in Public Citizen and BioMedEcon petitions seeking stronger labeling and other actions for dopamine agonists.
Attorney Jeffrey Shapiro calls on FDA to stop all enforcement oversight of laboratory-developed tests until Congress specifically defines the agencys ...
FDA and FTC send a joint Warning Letter to Rooted Apothecary (Naples, Florida) for illegally selling unapproved products containing cannabidiol online...
FDA makes available a final guidance entitled Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review.
FDA posts a final guidance entitled Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers.
FDA warns Chinas Jiangsu NHWA Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA approves eight smokeless tobacco products under the new modified risk tobacco product pathway.