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No FDA Senior Official Should Get High Post: Stupak

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Rep. Bart Stupak urges President-elect Obama not to appoint any current FDA senior executive as commissioner or even interim commi...

Nissen on FDA Commissioner Attributes, Agency Needs

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Reputed FDA commissioner candidate Steven Nissen gives a Washington conference his ideas on what both that job and FDA need most.

FDA Lists Handgun as Class 1 Medical Device

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A New Jersey gun maker gets FDA designation of an ergonomically designed, barely detectable single-shot pistol as a Class 1 medica...

Asthma Drugs Can Cause Problems: FDA Study

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FDA says long-acting beta agonists prescribed for managing asthma may cause increased risk of asthma complications under certain c...

Panel Asked About Synvisc-One Efficacy, Safety

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FDA asks the Orthopedic and Rehabilitation Devices Advisory Committee to comment on the efficacy and safety of Genzymes Synvisc-On...

Workshop on Sentinel Initiative

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Federal Register Notice: FDA co-sponsors with the eHealth Initiative Foundation a public workshop 12/16 on the Sentinel Initiative...

FDA Approves BD Pap Test Screening System

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FDA approves a BD Diagnostics PMA for the BD FocalPoint GS Imaging System as an aid in cervical cancer detection.

Gentas Tesetaxel is Orphan Drug

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FDA grants orphan drug status to Gentas tesetaxel, being developed to treat advanced melanoma.

Comments Sought on Device Reclassification

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Federal Register Notice: FDA seeks comments on reclassification petitions for medical devices.

FDA, WebMD Sign MOU to Provide Online Info

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Federal Register Notice: FDA provides a notice of a memorandum of understanding between FDA and WebMD, which will include a joint ...