Biologics
Theratechnologies sBLA for HIV Drug Administration
Theratechnologies files a supplemental BLA for Trogarzo (ibalizumab-uiyk) and an intravenous push form of administration for treating HIV-1 in combina...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 12/03/2021.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 12/3/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Members Sought for Mammography Panel
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advisory Committee.
Federal Register
Class 2 for Intraoperative Orthopedic Strain Sensor
Federal Register notice: FDA classifies the intraoperative orthopedic strain sensor into Class 2 (special controls).
Federal Register
Trunk/Limb Electrical Stimulator in Class 2
Federal Register notice: FDA classifies the trunk and limb electrical stimulator to treat headache into Class 2. (special controls).
Human Drugs
Lilly EUA for Monoclonal Antibodies Expanded
FDA revises an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab to be used in younger pediatric patients than previously au...
FDA General
No Imminent Retirement for Woodcock
FDA acting commissioner Janet Woodcock plans to play a senior role at the agency if FDA commissioner nominee Robert Califf is confirmed by the Senate.
Medical Devices
Congress Should Revamp 510(k) Process: Opinion
A Yale and Harvard opinion piece says Congress should use the upcoming Cures 2.0 bill draft and the reauthorization of the medical device user fee pro...
