FDA Related News

Federal Register

Ultrasound Cyclodestructive Device Reclassification Proposed

Federal Register notice: FDA issues a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class 3 device into Class ...

FDA Lifts Hold on Sarepta Gene Therapy Clinical Hold

FDA lifts a clinical hold against Sarepta Therapeutics against the companys Duchenne muscular dystrophy micro-dystrophin gene therapy program.

Human Drugs

Cook Medical 5mm Zilvr PTX Approved

FDA approves Cook Medicals new 5 mm diameter version of Zilver PTX, the first 5 mm peripheral artery disease drug-eluting stent in the U.S. with lengt...

Federal Register

Guide on Good Review Management Principles

FDA releases a draft guidance entitled Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.

Human Drugs

ANDA Submission Content and Format Guide

FDA releases a final guidance entitled ANDA Submissions Content and Format that details the information that should be provided in each section of th...

FDA Less Aggressive with Off-label Promotion: Woodcock

CDER director Janet Woodcock acknowledges that the pendulum has swung away from aggressive FDA drug advertising and promotion enforcement.

Federal Register

Patient Engagement Advisory Committee Meeting

Federal Register notice: FDA announces an 11/15 Patient Engagement Advisory Committee meeting to discuss and make recommendations on the topic Connect...

Human Drugs

CDER Priorities Include New Drugs Modernization

CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent director for the Office of...

Human Drugs

FDA Awards 12 Grants for Rare Disease Studies

FDA awards 12 new clinical trial research grants totaling more than $18 million over the next four years to help develop medical products for patients...

Medical Devices

Guide on 510(k) Benefit-Risk Factors

FDA issues a final guidance entitled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) wit...