Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 4/29/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 4/29/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Crohns Disease Draft Guidance Released
FDA posts a draft guidance entitled Crohns Disease: Developing Drugs for Treatment that discusses clinical trial considerations.
Federal Register
Gilead Sciences Gets Priority Voucher for Veklury
Federal Register notice: FDA issues a priority review voucher to Gilead Sciences under the agencys material threat medical countermeasure program.
Human Drugs
Clinical Hold Lifted on Finch C-diff Therapy
FDA lifts a clinical hold on a Finch Therapeutics Group IND for CP101, an orally administered microbiome therapeutic which is in late-stage clinical d...
Biologics
5 Tentative Dates for Covid Vaccine Panel Reviews
FDA announces the tentative Vaccines and Related Biological Products Advisory Committee schedule that has five separate dates the panel will meet to r...
Human Drugs
Guide on Ulcerative Colitis Drugs
FDA posts a draft guidance entitled Ulcerative Colitis: Developing Drugs for Treatment.
Human Drugs
FDA Puts Hold on Praxis Epilepsy Therapy
FDA sends an email to Praxis Precision Medicines that placed a clinical hold on PRAX-222, an antisense oligonucleotide for treating patients with SCN2...
Medical Devices
FDA Warns on Medtronic Heartware Ventricular Assist Device
FDA warns healthcare providers about the possibility that patients who have Medtronics Heartware Ventricular Assist Device System and appear to presen...
