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Zalicus Gains Orphan Drug Status for Z160

[ Price : $8.95]

FDA grants Zalicus an orphan drug designation for Z160, its first-in-class, selective N-type calcium channel modulator under devel...

FDA Orders New Boxed Warning on Pfizers Tygacil

[ Price : $8.95]

FDA orders a new Boxed Warning for Pfizers antibiotic Tygacil (tigecycline) to describe an increased risk of death when intravenou...

FDA Warning on Compounded Budesonide Solution

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FDA issues a warning to patients to not use nasal irrigation budesonide solution made at The Compounding Shop because it may be co...

FDA, Titan to Meet on Opioid Dependence Drug

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FDA grants a Titan Pharmaceutical request for a meeting to discuss its NDA and the agencys Complete Response Letter on its treatme...

Guidance on Color Additives in Animal Foods

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Federal Register Notice: FDA releases a guidance: Small Entity Compliance Guide Declaring Color Additives in Animal Foods.

FDA Corrects Notice on Secure Supply Chain Program

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Federal Register Notice: FDA corrects an e-mail address in an 8/20 Federal Register notice on the start of the secure supply chain...

Public Citizen Bashes Drug Compounding Bill

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Public Citizen says a Senate/House proposed compromise on a drug compounding bill would threaten patient safety by allowing outsou...

FDA Approves New Dosing Option for Hizentra

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FDA approves a new CSL Behring administration option for Hizentra (immune globulin subcutaneous human), 20% liquid to include dos...

CDRH Planning IDE Risk-Benefit Guidance

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CDRH Office of Device Evaluation regulations & guidance associate director Ashley Boam says the Center is developing a risk-benefi...

Glaxo Submits New Research on Inhalation Products

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GlaxoSmithKline says new research challenges FDAs proposed weight of the evidence approach to determining therapeutic equivalence ...