FDA issues a draft guidance to help applicants seeking licensure for a proposed biosimilar or interchangeable biosimilar for fewer than all of the ref...
Federal Register notice: FDA seeks comments on proposed research on Health Care Providers Understanding of Opioid Analgesic Abuse Deterrent Formulatio...
Federal Register notice: FDA makes available a final guidance entitled Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-...
Stakeholders comment on an FDA guidance and public workshop on patient-focused drug development.
Ropes & Gray attorneys review FDA enforcement action in a number of areas in 2019.
University researchers say nearly half of antibiotic fills for Medicaid patients do not involve treating an infection.
FDA releases an FDA-483 with five observations from an inspection at a Dr. Reddys API manufacturing facility in Andhra Pradesh, India.
FDA clears a Life Spine 510(k) for its Steerable Plateau Ti Spinal System.