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Info Collection Extension For Generic Drug Cover Sheet

[ Price : $8.95]

Federal Register notice: FDA announces an opportunity for public comment on an information collection extension entitled Generic D...

CDER Drug Inspection Common Deficiencies

[ Price : $8.95]

CDER Office of Process and Facilities branch chief Ying Zhang outlines common issues and deficiencies cited during pre‐appro...

Preempt State Liability for Branded Drug Label: WLF

[ Price : $8.95]

Washington Legal Foundation urges the Supreme Court to reject a 3rd Circuit Court of Appeals ruling that a preemption case should ...

CID Guidance, MAPPs Coming: Price

[ Price : $8.95]

CDER Division of Biometrics IV director Dionne Price outlines ways in which FDA will promote use of complex innovative trial desig...

Latest FDA Warning Letter

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes one medical product company Wilson Medicine Co.

Comments Reopened on Pediatric Device Development

[ Price : $8.95]

Federal Register notice: FDA reopens the comment the comment period provided in a 2/16 notice entitled Pediatric Medical Device De...

FDA Lifts Hold on Sarepta Gene Therapy Clinical Hold

[ Price : $8.95]

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

Cook Medical 5mm Zilvr PTX Approved

[ Price : $8.95]

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

Guide on Good Review Management Principles

[ Price : $8.95]

FDA releases a draft guidance entitled Good Review Management Principles and Practices for New Drug Applications and Biologics Lic...

ANDA Submission Content and Format Guide

[ Price : $8.95]

FDA releases a final guidance entitled ANDA Submissions Content and Format that details the information that should be provided i...