Federal Register
Drug Compounding Panel Discussing 4 Bulk Drugs
Federal Register notice: FDA announces a 6/8 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances that have been nomin...
Federal Register
Guide on Device Quality Improvement Program
Federal Register notice: FDA makes available a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Vo...
Federal Register
Draft Guide on Testosterone ANDA Bioequivalence
Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Testosterone.
Federal Register
Latest Federal Register Notices
FDA Review posts the the Federal Register notices for the week ending 5/6/2022.
Human Drugs
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 5/6/2022.
Medical Devices
Toxic Risk with Fresenius Hemodialysis Machines: FDA
FDA warns about the potential risk of exposure to toxic non-dioxin-like polychlorinated biphenyl acids and polychlorinated biphenyls with certain Fres...
Federal Register
Info Collection on Investigational Device Exemptions
Federal Register notice: FDA seeks comments on an information collection extension entitled Investigational Device Exemptions 21 CFR Part 812.
Medical Devices
Device Guidance on Voluntary Improvement Program
FDA releases a draft guidance entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.
Human Drugs
Myovant, Pfizer Myfembree sNDA Review Extended
Citing the need to assess just-submitted bone mineral density data, FDA extends its review of a Myovant Sciences and Pfizer supplemental NDA for Myfem...
