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Comments Sought on Antimicrobial New Animal Drugs

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Federal Register Notice: FDA seeks comments on a proposal on data collected from sponsors of antimicrobial new animal drugs.

Committees Reach Drug Compounding Agreement

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Members of the House and Senate say they are agreed on a bill that will increase FDA oversight of drug compounding and improve dru...

In Immediate Effect Guidances Soon from CDRH: Atty.

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Attorney Allyson Mullen sees CDRH soon issuing Immediate In Effect guidance documents.

Hamburg Promises Increased Cooperation with Device Makers

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During a plenary presentation at an AdvaMed conference, FDA commissioner Margaret Hamburg promises increased cooperation and colla...

BabyBIG Lot 5 Dosage Decreased to Extend Supply

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FDA approves a dosing decrease and extended expiration date for Lot 5 of botulism immune globulin intravenous (human), known as Ba...

CBER Cautions Tri-State Biologics

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CBER sends Tri-State Biologics a notice of violation about selling amniotic/chorionic-based injectable products without a valid bi...

Forest Sues Mylan Over Savella ANDA

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Forest sues Mylan over its ANDA for a generic form of Savella (milnacipran) tablets.

FDA Awards Peds Medical Device Grants

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FDA awards more than $3.5 million in grants to seven pediatric medical device consortia to increase development and availability o...

New Arzerra and Rituxan Boxed Warning

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FDA approves a new Boxed Warning for Arzerra and Rituxan about the risk of reactivation of hepatitis B infection.

Sunesis Enrolls 712 in Phase 3 Leukemia Trial

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Sunesis Pharmaceuticals completes enrollment of a Phase 3 VALOR trial of vosaroxin plus cytarabine in first relapsed or refractory...