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Federal Register

Comments Sought on Waiver Requests on Safety Reporting

Federal Register notice: FDA seeks comments on an information collection extension related to Providing Waiver-Related Materials in Accordance With th...

Federal Register

FDA Panel Meets to Review Victoza sNDA

Federal Register notice: FDA announces a 6/20 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a supplemental NDA for Novo Nor...

Federal Register

Comments Sought on Drug Ad Information Reporting Extension

Federal Register notice: FDA seeks comments on an information collection extension on Prescription Drug Advertisements; OMB Control Number 09100686....

Human Drugs

Celgene Reports Positive Data in Multiple Sclerosis Trial

Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple...

Human Drugs

No Risks Cited in Gadolinium-based Product Review: FDA

An ongoing FDA review of the risk of brain deposits following repeated use of gadolinium-based contrast agents for MRIs identifies no adverse health e...

Medical Devices

Respironics Class 1 Recall of Ventilators

Respironics begins a Class 1 recall of its V60 Non-invasive Ventilator because the pins within the internal cable that connects the ventilator's motor...

Medical Devices

Soterix Medical Iontophoresis Device Cleared

FDA clears a Soterix Medical 510(k) for its IontoDC device, which uses a direct current to introduce ions of soluble salts or other drugs into the bod...

Human Drugs

Celgene Reports Positive Data in Multiple Sclerosis Trial

Celgene says its Phase 3 RADIANCE trial met its primary endpoint in evaluating the efficacy and safety of ozanimod in patients with relapsing multiple...

Human Drugs

FDA Releases Sancilio, FL Form 483

FDA releases a Form 483 after a January inspection cited significant GMP issues at Sancilio & Co.s Riviera Beach, FL manufacturing facility.

Human Drugs

Panel to Review FDA Concerns on Puma Breast Cancer Drug

A 5/24 FDA Oncologic Drugs Advisory Committee plans to discuss agency concerns over uncertainty in the magnitude of treatment effect due to unplanned ...