Federal Register
Federal Register Notices 12/20-12/30
FDA Review posts the following Federal Register notices that published during our annual holiday break (12/20-12/30).
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 12/31/2021.
Human Drugs
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Medical Devices
Baxter Volara System Recall is Class 1
FDA says the Baxter Healthcare recall of its Volara system due to risk of respiratory distress in home use is Class 1.
Explain Need for Trial Diversity: Caplan
New York University bioethicist Arthur Caplan says those calling for greater diversity in clinical trials should clearly explain the benefits of such ...
Federal Register
Nominations Sought for Device Panels
Federal Register notice: FDA seeks nominations for voting members to serve on CDRHs Medical Devices Advisory Committee device panels.
Medical Devices
FDA Mulls 510(k) Sterilization Master File
FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices.
Federal Register
Draft Guide on Inspecting for Particulates
Federal Register notice: FDA makes available a draft guidance for industry entitled Inspection of Injectable Products for Visible Particulates.
Federal Register
Manual Percutaneous Surgical Set is Class 2
Federal Register notice: FDA classifies the manual percutaneous surgical set assembled in the abdomen into medical device Class 2 (special controls).
Human Drugs
CDER Ramps Up Enforcement of ClinicalTrials.gov Compliance
CDER Office of Compliance director Donald Ashley says the Center has ramped up its enforcement of ClinicalTrials.gov compliance, specifically registra...
