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Medical Devices

Bakul Patel Leaving CDRH After 13 Years

After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel announces he will be leaving the agency early this month t...

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Crohns Disease Draft Guidance Released

FDA posts a draft guidance entitled Crohns Disease: Developing Drugs for Treatment that discusses clinical trial considerations.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FDA posts a draft guidance entitled Ulcerative Colitis: Developing Drugs for Treatment.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...