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 ...
FDA warns about the potential risk of exposure to toxic non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls with certain Fres...
FDA issues a partial clinical hold on BioCryst clinical trial of its oral Factor D inhibitor, BCX9930 due to observed elevations in serum creatinine s...
Federal Register notice: FDA sends to OMB an information collection extension entitled Antimicrobial Animal Drug Distribution Reports and Recordkeepin...
Psychiatrist Brian Barnett says FDA should remove itself from neutrophil monitoring requirements for patients on clozapine and leave the issue to pres...
FDA publishes a guidance with recommendations for feasibility and early feasibility studies in medical devices intended to improve glycemic control in...