• where experts go to learn about FDA
  • Sara W. Koblitz

    • At long last, FDA Issues Guidance on Biosimilar InterchangeabilityJanuary 17th, 2017

      After months of promises and postponements, FDA has finally published its long-awaited draft guidance on biological product interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product, under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).  While FDA had originally promised the guidance in …

    • FDA Issues “One-Stop Shop” Draft Guidance Document on Post-MMA 180-Day ExclusivityJanuary 13th, 2017

      Last January, when FDA issued the Agency’s Calendar Year 2016 Guidance Agenda, we were pretty stoked to seek guidance was planned on various ANDA and Hatch-Waxman issues, including “Three-Year Exclusivity Determinations for Drug Products;” “Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products;” …