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Despite Report, FDA Sees No Surge in Drug Recalls

[ Price : $8.95]

FDA counters a Stericycle ExpertRecall Report showing a 127% surge in recent drug recalls with its own data showing no such surge.

Public Meeting on Fibromyalgia Drug Development

[ Price : $8.95]

Federal Register Notice: FDA plans a public meeting 12/10 on patient-focused drug development for fibromyalgia.

Panel to Discuss Pharmaceutical Product Quality

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Federal Register Notice: FDAs Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 10/30 to discuss s...

Panel to Discuss Pharmaceutical Continuous Manufacturing

[ Price : $8.95]

Federal Register Notice: FDAs Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 10/31 to discuss c...

Public Workshop on Developing Pediatric Devices for Rare Diseases

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Federal Register Notice: FDA will hold a public workshop 1/8/14: Complex Issues in Developing Medical Devices for Pediatric Patien...

Workshop on IV Fat Emulsion Products

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Federal Register Notice: CDER will co-sponsor a public workshop 10/26: Clinical Trial Design for Intravenous Fat Emulsion Products...

FDA Rejects Merck NDA Resubmission for Sugammadex

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FDA issues Merck a Complete Response Letter on its NDA resubmission for sugammadex sodium injection, indicated for reversing neuro...

Easier, Faster Inspections or Objective, Honest Ones?

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Editor Jim Dickinson analyzes the apparent scope of FDA commissioner Margaret Hamburgs new Program Alignment Group and sees a pote...

CDER Partially Grants/Denies Petitions on Suboxone 505(b)(2) NDAs

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CDER partially grants and denies requested actions in two citizen petitions filed by Hyman, Phelps & McNamara seeking restrictions...

CDRH Final Guidance on Mobile Medical Applications

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A final guidance says CDRH intends to focus its oversight on mobile medical applications that are intended to be used as an access...