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FDA warns Chinas Wuxi Medical Instrument Factory about CGMP violations in its manufacturing of finished pharmaceuticals.[ Price : $8.95]
FDA warns Preservation Solutions about Quality System violations in its manufacturing of organ transplant preservation solution.[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency is developing a guidance document on real world evidence (RWE) consensus definitio...[ Price : $8.95]
Federal Register notice: FDA extends the comment period for the public meeting on Administering the Hatch-Waxman Amendments: Ensur...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Firson Co., Nova Homeopathic Therapeutics, Preservation Solutions a...[ Price : $8.95]
FDA approves GlaxoSmithKlines Trelegy Ellipta COPD product and denies a Boehringer Ingelheim petition seeking to impose conditions...[ Price : $8.95]
FDAs Oncologic Drug Advisory Committee gives a mixed voted on the benefit-risk profile for Pfizers Sutent (sunitinib) as adjuvant ...[ Price : $8.95]
Continuing FDA safety concerns involving PD-1/PD-L1 inhibitors spread to two Roche clinical trials, placing them on partial clinic...