Federal Register notice: FDA makes available a final guidance entitled Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices ...
A new Pew Charitable Trusts survey on lab-developed tests finds that most participants would favor increased FDA oversight in this space.
FDA commissioner Robert Califf admits that his return to the FDA top post gives him an opportunity to address unfinished business from the first time ...
Lasik injury advocate and Vision Advocacy president Paula Cofer steps up pressure to get FDA commissioner Robert Califfs attention to address illegal ...
Eleven CDER staffers say a Center self-audit of continuous manufacturing regulatory submissions verifies the benefits the agency has seen in such tech...
FDA approves a new indication for Daiichi Sankyos Enhertu for some breast cancer patients.
FDA-sponsored research demonstrates that patients who switch between generic levothyroxine products maintain the same level of thyroid function as pat...
FDA releases the FDA-483 with 15 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.