FDA releases its latest batch of Warning Letters that include CooperSurgical and Dr. Paul's Lab.
GSK Healthcare asks FDA to change its approach in a draft guidance on labeling OTC drugs.
FDA says Pacific Stem Cells is marketing unapproved stem cell products to treat several diseases and conditions.
FDA clears a Piccolo Medical 510(k) for its SmartPICC System that is intended to give healthcare providers the ability to navigate peripherally insert...
A new study finds that racial/ethnic minority groups and older adults are underrepresented in U.S.-based vaccine clinical trials.
Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practices and Related Regulatio...
Federal Register notice: FDA seeks public comments on an information collection extension associated with its Guidance for Industry and FDA Staff Cla...
Federal Register notice: FDA sends to OMB an information collection extension entitled Dispute Resolution Procedures for Science-Based Decisions on Pr...