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Teva Wants Generic QVAR to Have Dose Counter

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Teva asks FDA to require a dose counter in any generic form of its QVAR inhalation aerosol.

Regulatory Creep Seen in FDA Inspection Guidance

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Attorneys Jay Cormier and Anne Walsh say an FDA final guidance on company actions to limit or refuse an agency inspection contains...

Panel to Discuss Antibacterials for Serious Infections

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 12/4 to discuss clinical development programs and ...

Guidance on Delaying a Drug Inspection

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Federal Register Notice: FDA is making available a guidance: Circumstances that Constitute Delaying, Denying, Limiting, or Refusin...

Blood Products Panel to Meet

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Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/2-3 to hear data on the blood donor policy, the chiku...

Relypsa Files NDA for Patiromer

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Relypsa files an NDA for patiromer for oral suspension for treating hyperkalemia, a serious condition defined as abnormally elevat...

FDA Panel Backs Expanded Kalydeco Use in Cystic Fibrosis

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FDA advisory committee recommends expanded approval of Vertex Pharmaceuticals Kalydeco (ivacaftor) in people with cystic fibrosis ...

Drug Repackager Recalls Naproxen Cartons That Contain Ibuprofen

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Greensboro, NC-based Contract Packaging Resources recalls 11,640 boxes of Assured brand naproxen sodium tablets because some carto...

Hamburg Touts FDA Rare Disease Efforts

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FDA commissioner Margaret Hamburg says agency efforts to encourage development of new treatments for rare diseases are paying off.

Homeland Security Probing Device Cyber Flaws

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Reuters reports that the Department of Homeland Security is looking at two dozen medical devices that could be susceptible to cybe...