CDER Office of Surveillance and Epidemiology researchers say more work is needed to address bias introduced by stimulated adverse event reporting on s...
FDA warns Orchid Orthopedic Solutions about Quality System violations in its work applying coatings to some orthopedic implants.
Stakeholders comment after an FDA public hearing on enhancing incorporation of patients perspectives in clinical trials.
FDA clears a Body Vision Medical 510(k) for the LungVision 2.0 System.
A Friends of Cancer Research/Parker Institute white paper explores designing the future of cell therapies for various cancers.
FDA releases its latest batch of Warning Letters that includes Centurion Laboratories, Orchid Orthopedic Solutions, Rechargeable Power Energy and Zell...
A revised safety update on Abiomed's Impella RP System emphasizes proper patient selection after interim post-approval study results indicated a lower...
FDA posts a draft guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Consideratio...