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OMB Approves Info on Sample/Protocol Requests

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Federal Register Notice: The Office of Management and Budget approves a collection of information on requests for samples and prot...

Comments Sought on Exempting Cranial Orthosis Devices

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Federal Register Notice: FDA receives a petition requesting exemption from premarket notification requirements for cranial orthosi...

FDA Approves Altana Allergy Nasal Spray

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FDA approves an Altana Pharma NDA for Omnaris (ciclesonide) nasal spray for treating allergic rhinitis nasal symptoms.

Changes Sought in Warning Letter System

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Attorney Larry Pilot, who represented Utah Medical in its successful fight against FDA Warning Letters, says FDA should develop a ...

FDA Asks for New Studies on Antibiotic

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FDA issues a non-approvable letter to Replidyne Inc. on its NDA for antibiotic faropenem medoxomil, and requests additional studie...

Global Harmonization Documents Out

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FDA says Global Harmonization Task Force documents are available.

FDA Spokeswoman Bro Joins Caremark Rx

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FDAs chief spokeswoman, Susan Bro, resigns to join Caremark Rx as corporate communication senior vice president.

FDA OKs Betaseron for Expanded Use in MS

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FDA approves Berlexs Betaseron for an expanded use in patients with multiple sclerosis who have experienced their first clinical e...

Risk of Guillain Barre Syndrome with Menactra

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FDA says it is still seeing a few cases of Guillain Barre Syndrome being reported in patients receiving Sanofi Pasteurs Menactra v...

Despite Outliers Industrys Compliance is Good

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Consulting editor John Scharmann reviews industrys compliance record since 2001 and concludes that high-publicity outliers aside, ...