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Human Drugs

Gilead Bags Priority Review Voucher from Sarepta for $125 Million

Sarepta Therapeutics enters into an agreement to sell to Gilead its FDA Rare Pediatric Disease Priority Review Voucher for $125 million.

FDA General

Consent Decree Entered Against Dietary Supplement Maker

The U.S. District Court for the Western District of Louisiana enters a consent decree against dietary supplement maker Pick and Pay Inc./Cili Mineral ...

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 2/17/2017.

FDA General

Latest Federal Register Notices

FDA Review posts the latest Federal Register notices posted the week ending 2/17/2017.

Federal Register

FDA Debars Raymond Brown Over Foreign-Sourced Botox

Federal Register Notice: FDA issues an order to permanently debar Raymond Sean Brown from providing services in any capacity to a person that has an a...

FDA General

GAO Criticizes FDA Foreign Office Staffing, Drug Shortages

The Government Accountability Office criticizes FDA staff vacancies at foreign agency posts and continued struggles with drug shortages as part of its...

Federal Register

FDA Debarment Order Against Karis Delong

Federal Register Notice: FDA issues an order debarring Karis Copper Delong for a period of 12 years from providing services in any capacity to a perso...

Human Drugs

FDA Approves Perrigo ANDA for Cough Medicine

FDA approves a Perrigo ANDA for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5mg/1.5mg per 5mL, indicated for cough.

Human Drugs

CTTI Recommendations on Pediatric Antibacterial Development

The Clinical Trials Transformation Initiative releases new recommendations to streamline and improve pediatric trials in antibacterial drug developmen...

Human Drugs

ICH Q & A Guideline on Starting Materials Posted

FDA posts an International Council for Harmonization guideline on Q11 Implementation Working Group Development and Manufacture of Drug Substances (Che...