Latest Federal Register Notices
Draft Guide on Population Pharmacokinetics
Federal Register notice: FDA makes available a draft guidance entitled “Population Pharmacokinetics (PK)” to assists sponsors in applying PK during drug development. 09/25/2020
Draft Guide on Hormonal Drug Product Development
Federal Register notice: FDA releases a draft guidance on Hormonal Contraceptive Drug Product Development. 09/25/2020
Guide on IDE Live Case Presentations
Federal Register notice: FDA makes available a guidance entitled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.” 09/24/2020
Draft Guide on Harmonizing Drug Compendial Standards
Federal Register notice: FDA makes available a draft guidance entitled “Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.” 09/23/2020
Draft Guide on Inactive Ingredient Database
Federal Register notice: FDA makes available a draft guidance entitled “Using the Inactive Ingredient Database.” 09/23/2020
11 ‘No-Longer-Marketed’ NDAs Withdrawn
Federal Register notice: FDA withdraws approval of 11 NDAs from multiple applicants because the products are no longer marketed. 09/22/2020