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Review Period Set for Byetta

[ Price : $8.95]

Federal Register Notice: FDA determines the regulatory review period for Amylin Pharmaceutcals Byetta for the purpose of patent ex...

FDA Priority Review for Arixtra sNDA

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FDA grants a priority review for a GlaxoSmithKline supplemental NDA for its anticoagulant product Arixtra to be used for treating ...

FDA OKs Boston Sceintifics Latitude Home Monitoring

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FDA approves Boston Scientifics Latitude Patient Management System to be used with all of the companys implantable defibrillators ...

FDA Dirty Tricks and Silence Policy are Most-read News

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FDA dirty tricks against two small medical device companies and the agencys growing policy of silence when challenged are the subj...

Compounded Horse Drug Consent Decree Signed

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A federal judge approves a consent decree between FDA and BET Pharm calling for the company to destroy unapproved new drugs it com...

FDA Approves Nerve Poisoning Treatment

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FDA approves Meridian Medical Technologies Duodote for use in treating civilians exposed to nerve poisoning agents such as sarin o...

Trasylol Events Underscore FDA Struggles with Safety Info

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FDAs continuing struggle with how it releases safety information on marketed drugs is seen in 9/29 events related to Bayers Trasyl...

2nd Medtronic Warning Letter in 30 Days

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FDA sends Medtronic its second Warning Letter in less than 30 days.

Comments Extended on Unapproved Animal Drugs

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Federal Register Proposed rule: FDA extends the comments period to 12/20 on the index of legally marketed unapproved new animal dr...

Guidance on Quality Systems Approach to GMPs

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Federal Register Notice: FDA releases a guidance on quality systems approach to pharmaceutical current good manufacturing practice...