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CDRH Denies Petition Seeking Philips Device Recalls

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CDRH denies a 2009 citizen petition from a private individual to force a recall of all Philips medical devices affected by Philips...

FDA Approves Brintellix for Depression

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FDA approves a Takeda Pharmaceuticals and Lundbeck NDA for Brintellix (vortioxetine), indicated for treating adults with major dep...

House Passes Drug Compounding Bill

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The House of Representatives passes by a voice vote H.R. 3204, the Drug Quality and Security Act, which seeks to improve drug safe...

Medtronic Hit with Warning Letter as Part of MiniMed Approval

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FDA approves a Medtronic PMA for its MiniMed 530G artificial pancreas system along with a Warning Letter seeking manufacturing cor...

Zalicus Gains Orphan Drug Status for Z160

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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

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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...