Latest Federal Register Notices
Guide on Cell/Tissue-Based Product Regulatory Considerations
Federal Register notice: FDA releases a guidance on “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Minimal Manipulation and Homologous Use.” 11/17/2017
Expedited Programs for Regenerative Medicines Draft Guidance
Federal Register notice: FDA makes available a draft guidance on “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” 11/17/2017
Bone Drugs Panel to Review Lipocine Testosterone NDA
Federal Register notice: FDA announces a 1/10/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting that will discuss a Lipocine Inc. NDA for oral testosterone undecanoate capsules. 11/16/2017
Final Decision on Mepergan Fortis sNDA Administrative Review
Federal Register notice: FDA announces that an initial decision of the administrative law judge (ALJ) is now the final agency decision on refusing approval of a supplemental NDA for Mepergan Fortis capsules (meperidine HCl, promethazine HCl). 11/16/2017
Draft Guide on GRAS Panel Best Practices
Federal Register notice: FDA makes available a draft guidance on “Best Practices for Convening a GRAS Panel.” 11/16/2017
Draft Guide on Biosimilar User Fees
Federal Register notice: FDA makes available a draft guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” 11/16/2017