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.
FDA accepts for review an IntelGenx 505(b)(2) NDA resubmission for Rizaport VersaFilm (rizatriptan ) an oral disintegrating film for treating acute mi...
FDA releases its latest batch of Warning Letters that includes Jiangsu NHWA Pharmaceutical Co. and Sofie Co.
Three stakeholders raise concerns with an FDA guidance on gastroparesis drug development.