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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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Petition Seeks Confusion Warning on Anticholinergic Products

[ Price : $8.95]

A citizen petition seeks a warning to the labeling of all nonprescription drug products containing an ingredient with anticholiner...

Petition Lingered 21 Years at FDA Until Just Denied

[ Price : $8.95]

FDA denies a 21-year-old citizen petition seeking the market withdrawl of doxylamine succinate.

FDA Posts UDI Final Rule for Medical Devices

[ Price : $8.95]

FDA issues a long-awaited final rule on establishing a unique device identifier system to identify devices through distribution an...

Guidance on Endocrine Disruption Potential of Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.