FDA warns about the potential risk of exposure to toxic non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls with certain Fres...
Federal Register notice: FDA seeks comments on an information collection extension entitled Investigational Device Exemptions 21 CFR Part 812.
FDA releases a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.
Citing the need to assess just-submitted bone mineral density data, FDA extends its review of a Myovant Sciences and Pfizer supplemental NDA for Myfem...
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 ...