A Washington Legal Foundation posts reviews a Pennsylvania case determining whether strict liability claims may be allowed for prescription medical de...
FDA issues two draft guidances aimed at speeding generic drug development and marketing.
Federal Register final rule: FDA issues a final rule to revise the animal drug regulations for new animal drug residue tolerances.
Federal Register notice: FDA releases a guidance entitled Risk Evaluation and Mitigation Strategies: Modifications and Revisions that outlines how to ...
FDA posts a final guidance entitled Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.
Medical Research Collaborative asks FDA to remove an Amarin Vascepa patent from the Orange Book.
FDA accepts for review a Sanofi BLA for isatuximab for treating patients with relapsed/refractory multiple myeloma.
FDA clears a Centerline Biomedical 510(k) for the Intra-Operative Positioning System.