Federal Register
Drug Supply Chain Security Info Collection
Federal Register notice: FDA sends to OMB an information collection revision entitled Drug Supply Chain Security Act Implementation (OMB Control Numbe...
Medical Devices
Guide on Device Supply Discontinuance/Interruption
FDA posts a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...
Human Drugs
Allogene Therapeutics Clinical Hold Removed
FDA removes a clinical hold on Allogene Therapeutics AlloCAR T clinical trials after a chromosomal abnormality was determined to be unrelated to the t...
Medical Devices
Cardiovascular Systems Recall Wirion Device
Cardiovascular Systems recalls its Wirion system due to complaints about filter breakage during retrieval.
Human Drugs
Fast Track for Retinal Therapy
FDA grants 4D Molecular Therapeutics a fast track designation for 4D-125 for treating patients with inherited retinal dystrophies due to defects in th...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 1/7/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 1/7/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Court Rules Against FDA in Vaccine FOIA Request
A Texas federal court rules against FDA in a Freedom of Information Act lawsuit by a group seeking data and information on the Pfizer/BioNTech Covid-1...
Human Drugs
Moderna Booster Shot Shortened to 5 Months
FDA amends the emergency use authorization for the Moderna Covid-19 vaccine to shorten the time between the completion of primary vaccination with the...
