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FDA OKs NovaDel Pharmas NitroMist for Angina

[ Price : $8.95]

FDA approves a NovaDel Pharma NDA for NitroMist indicated for treating angina pectoris.

CoMeD Asks Stay of Petition Denial

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The Coalition for Mercury-free Drugs asks HHS and FDA not to implement FDAs denial of the groups citizen petition dealing with mer...

Comments Sought on Premarket Notification

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Federal Register Notice: FDA seeks comments on a collection of information on premarket notification for devices.

Device Clinical Trial Quality Units Urged by FDA

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CDRH BIMO director Michael Marcarelli urges device sponsors/researchers to establish clinical trial quality units to oversee the ...

California Looking Into Zyprexa Marketing

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Lilly is hit with a California probe of Zyprexa marketing and promotion.

Safety, Critical Path Said to Get More FDA Resources

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A Washington conference is told that FDA had identified four areas, including safety and the Critical Path Initiative, to receive ...

FDA OKS Impax Labs Generic Urecholine

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FDA approves an Impax Laboratories ANDA for a generic version of Odyssey Pharmaceuticals Urecholine tablets.

FDA Sends Info on Device User Fees to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the medical device user fee cover sheet to the Office...

Comments Sought on Sample Electronic Products

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Federal Register Notice: FDA seeks comments on requirements for sample electronic products for manufacturers and distributors of e...

FDA Submits Info on Device Inspections to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the devices inspection by accredited persons program ...