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FDA General

MDIC Taps Booze Allen for Cybersecurity Help

FDA and the Medical Device Innovation Consortium announce a partnership with Booz Allen Hamilton to establish a benchmark of the medical device indust...

Human Drugs

FDA Corrects CytoDyn Misinformation on Leronlimab

In a rare step, FDA publicly corrects CytoDyn misinformation about an investigational therapy for treating Covid-19 patients.

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 5/14/2021.

Federal Register

Comments Sought Peptide Clin/Pharm Evaluations

Federal Register notice: FDA opens a public docket for comments on Evaluating the Clinical Pharmacology of Peptides.

Federal Register

Ovide Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Taro Pharmaceutical Industries Ovide (malathion) lotion, 0.5%, was not withdrawn due to safety or effecti...

Federal Register

FDA Debars Drug Wholesaler Rick Shepard

Federal Register notice: FDA issues an order debarring Rick Shepard for five years from importing or offering for import any drug into the U.S.

Federal Register

Panel to Hear Classifications for 6 Preamendment Devices

Federal Register notice: FDA announces a 6/3-4 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that will make classifica...

Medical Devices

Revised Guide on Device Premarket Cybersecurity Soon

CDRH cybersecurity policy analyst Matthew Hazelett says the Center expects to release by the end of the year an updated draft guidance on medical devi...

Federal Register

Oncologic Panel to Vote on Incyte BLA

Federal Register notice: FDA announces a 6/24 Oncologic Drugs Advisory Committee that will discuss an Incyte BLA for retifanlimab injection.

Biologics

Biogen Therapy for Retinal Disease Misses Endpoint

Biogen says its Phase 2/3 XIRIUS study of cotoretigene toliparvovec, a gene therapy being investigated for patients with X-linked retinitis pigmentosa...