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 around.”
Lasik injury advocate and Vision Advocacy president Paula Cofer steps up pressure to get FDA commissioner Robert Califf’s attention to address “illegal” advertising by refractive eye surgeons.
FDA warns about the potential risk of exposure to toxic non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls with certain Fresenius Medical Care hemodialysis machines.
FDA issues a partial clinical hold on BioCryst clinical trial of its oral Factor D inhibitor, BCX9930 due to observed elevations in serum creatinine seen in some patients.
Federal Register notice: FDA sends to OMB an information collection extension entitled “Antimicrobial Animal Drug Distribution Reports and Recordkeeping — 21 CFR 514.87.
Psychiatrist Brian Barnett says FDA should remove itself from neutrophil monitoring requirements for patients on clozapine and leave the issue to prescribers.
FDA publishes a guidance with recommendations for feasibility and early feasibility studies in medical devices intended to improve glycemic control in patients with Type 2 diabetes.
A House Energy and Commerce Committee legislative package to reauthorize FDA user fee agreements aims to address agency predicaments caused by recent court decisions affecting orphan drug exclusivity and the regulation of contrast agents.
Federal Register notice: FDA makes available a draft guidance entitled “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies.”