The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

The MAGiC catheter is designed to perform minimally invasive cardiac ablation procedures that treat various forms of ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a ...

ST. LOUIS — A newly FDA-approved procedure allows patients to regrow their own knee cartilage using autologous cell implantation. The treatment, known as MACI (Matrix Autologous Chondrocyte ...

Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...