Stakeholders raise questions on an FDA draft guidance on submitting IND safety reports in electronic format to FAERS.
Teva agrees to pay $54 million to settle a whistleblower suit alleging that it used sham speaker and consulting programs to reward doctors for prescri...
FDA releases its latest batch of Warning Letters that includes one medical product company Apollo Health and Beauty Care.
FDA grants Precigen an orphan drug designation for PRGN-3006, a first-in-class investigational therapy for treating patients with relapsed or refracto...
FDA warns Canadas Apollo Health and Beauty Care about CGMP violations in its work as a contract manufacturer of OTC drugs.
Federal Register notice: FDA announces a 3/4 Vaccines and Related Biological Products Advisory Committee meeting to discuss upcoming flu vaccines.
Federal Register notice: FDA renews for two years the charter for its Patient Engagement Advisory Committee.
Federal Register notice: FDA has renewed for another two years the charter for its Pharmaceutical Science and Clinical Pharmacology Advisory Committee...