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FDA releases a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Impr...[ Price : $8.95]
Citing the need to assess just-submitted bone mineral density data, FDA extends its review of a Myovant Sciences and Pfizer supple...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Feasibility and Early Feasibility Clinical Studies for Cert...[ Price : $8.95]
A new Pew Charitable Trusts survey on lab-developed tests finds that most participants would favor increased FDA oversight in this...[ Price : $8.95]
FDA commissioner Robert Califf admits that his return to the FDA top post gives him an opportunity to address unfinished business ...[ Price : $8.95]
Lasik injury advocate and Vision Advocacy president Paula Cofer steps up pressure to get FDA commissioner Robert Califfs attention...[ Price : $8.95]
Eleven CDER staffers say a Center self-audit of continuous manufacturing regulatory submissions verifies the benefits the agency h...[ Price : $8.95]
FDA approves a new indication for Daiichi Sankyos Enhertu for some breast cancer patients.