FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 4/15/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Medical Devices
FDA Clears SonoScape Video Endoscopy Device
FDA clears a SonoScape 510(k) for its flagship video endoscopy system HD-550 for gastrointestinal diagnosis.
Federal Register
Info Collection on Quick Turnaround Surveys
Federal Register notice: FDA seeks comments on an information collection extension for Generic Clearance for Quick Turnaround Testing of Communication...
Federal Register
Guide on Bioavailability Studies for Drug Submissions
Federal Register notice: FDA makes available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs General Considerations.
Human Drugs
Ukoniq Withdrawn Due to Overall Survival Concerns
Due to overall survival concerns, TG Therapeutics withdraws its accelerated approval of Ukoniq (umbralisib), a PI3K inhibitor for treating adults with...
Human Drugs
Hiers Enterprises Hit With 483 After Inspection
FDA issues Hiers Enterprises (dba Northwest Compounding Pharmacy) a Form FDA-483 after inspecting the firm in 11/2021.
Human Drugs
aTyr Pharma Gets Orphan Status on Efzofitimod
FDA grants aTyr Pharma an orphan drug designation for efzofitimod and its use in treating systemic sclerosis.
Biologics
Amneal BLA for Avastin Biosimilar Approved
FDA approves an Amneal Pharmaceuticals BLA for bevacizumab-maly, a biosimilar referencing Genentechs Avastin.
Human Drugs
Shelf Life Evaluation for Bamlanivimab and Etesevimab
FDA and HHS says that the shelf-life of Eli Lillys bamlanivimab and etesevimab, for treating Covid-19, are being evaluated, and an update regarding a ...
