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.
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...
A House Energy and Commerce Committee legislative package to reauthorize FDA user fee agreements aims to address agency predicaments caused by recent ...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studie...