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Federal Register

Panel to Review Makena Unfavorable Study

Federal Register notice: FDA announces a 10/29 advisory committee meeting to review an Amag Pharma confirmatory clinical trial that did not meet its c...

Human Drugs

MAPP on Patient-Oriented Labeling Consults

CDER issues a MAPP with procedures to be followed when its Division of Medication Error Prevention consults its Division of Medical Policy Programs fo...

Human Drugs

Dietary Supplement CGMP Violations at Nutra Solutions

FDA warns Nutra Solutions about CGMP violations in its work as a contract manufacturer of dietary supplements.

Human Drugs

FTC Questions Ads for Drug Company Lawsuits

FTC warns seven unidentified legal practitioners and lead generators that TV ads soliciting clients to sue drug companies may be deceptive or

Human Drugs

AveXis Fires 2 Execs for Data Manipulation

AveXis tells FDA it has terminated two senior executives who were the subject of a company investigation into data manipulation for its Zolgensma.

Medical Devices

FDA OKs Cardiovascular Systems ViperWire

FDA approves a Cardiovascular Systems PMA for its ViperWire Advance Coronary Guide Wire with Flex Tip.

Federal Register

Final Guide for ALS Drug Development

Federal Register notice: FDA makes available a final guidance entitled Amyotrophic Lateral Sclerosis (ALS): Developing Drugs for Treatment.

Human Drugs

Clinical Hold on Abeona Gene Therapy

FDA places a clinical hold on an Abeona Therapeutics planned Phase 3 clinical trial for EB-101 until it submits additional data points on transport st...

Human Drugs

Oncologists Respond Swiftly to FDA Safety Alerts: Study

Researchers say oncologists can move quickly when FDA issues new safety information on therapies approved under accelerated approval programs.

Human Drugs

Latest FDA Warning Letter

FDA releases its latest batch of Warning Letters that includes one medical product company Nutra Solutions USA.