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Panel Recommends Approving Hologic Sterilization

[ Price : $8.95]

FDA advisors recommend approving a pre-market application for Hologics Adiana permanent contraception.

Duramed Sues Watson Over Generic Seasonale

[ Price : $8.95]

Duramed Pharmaceuticals files suit against Watson Pharmaceuticals for patent infringement involving a generic copy of Seasonale.

Tykerb Launch Letters Misleading

[ Price : $8.95]

DDMAC warns GlaxoSmithKline about risk minimization in launch letters to healthcare professionals for its breast cancer drug Tyker...

FDA Clears Varian Proton Scanning Algorithm

[ Price : $8.95]

FDA clears a Varian Medical Systems 510(k) for a proton scanning dose algorithm for the companys Eclipse treatment software.

FDA Issues Two Draft Harmonized Guidances

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FDA issues draft harmonized guidances as annexes to the evaluation and recommendation of pharmacopeial texts.

Advisors Want More OTC Decongestant Studies

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Members of two FDA advisory committees say there is some evidence that phenylephrine is an effective decongestant but want more da...

Bedfords Levothyroxine in Short Supply

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FDA says Bedford Laboratories levothyroxine sodium lyophilized powder for injection is in short supply.

FDA Funding Boosters Merge

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The two external constituency organizations lobbying for higher congressional appropriations for FDA decide to merge as the Coalit...