Federal Register
Comments Extended for Drug Scheduling Notice
Federal Register notice: FDA is reopening the comment period for a 7/23 notice on international drug scheduling convention for five narcotic drugs.
Biologics
AstraZeneca Can Export Vaccine Made at Emergent Bio: FDA
CBER says AstraZeneca can export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions troubled contract manufacturing f...
Biologics
Pfizer/BioNTech Booster Data Submitted to FDA
Pfizer and BioNTech submit Phase 1 data to FDA to support the evaluation of a booster dose of their Covid-19 vaccine.
Federal Register
Latest Federal Register Notices
FDA Review has posted the Federal Register notices for the week ending 8/13/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
FDA Sends Sesen Bio a Complete Response Letter
FDA issues Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating BCG-unresponsive non-muscle invasive b...
Human Drugs
CDERs Ellis Unger Retiring After 24 Years at Agency
CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger retires to spend more time with family.
Federal Register
Drug User Fee Rates for FY 2022
Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2022.
Biologics
Pfizer, Moderna Booster Authorized for Immunocompromised
FDA amends the emergency use authorizations for both Pfizer-BioNTechs and Modernas Covid-19 vaccines to allow for the use of an additional dose in cer...
Human Drugs
Ipsen Withdraws NDA Palovarotene for More Analyses
Ipsen withdraws its NDA palovarotene, indicated for preventing heterotropic ossification as a potential treatment for people living with fibrodysplasi...
