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FDA Approves New Seroquel Indication

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FDA approves AstraZenecas Seroquel XR as adjunctive treatment to antidepressants for adults with major depressive disorder.

Panel Gives Good Grades on FDAs New Leadership

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A panel of FDA Watchers at an industry conference gives the agency new leadership high passing marks on its attempts to improve FD...

Guidance on Liquid Dietary Supplements

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Federal Register Notice: FDA releases a draft guidance on factors that distinguish liquid dietary supplements from beverages from ...

Advisors to Look at Pediatric Safety Reviews

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FDA says its Pediatric Advisory Committee will review safety profiles for 13 drugs at its 12/8 meeting.

FDA Plans Spring 2010 Advisory Meeting on Opioid REMS

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FDA says it will consider information presented by an industry working group on opioid REMS and take its recommendations to an adv...

PDUFA Goals Back on Track, Jenkins Says

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Office of New Drugs director John Jenkins says a two-year hiring push at CDER has added enough new staff that the Center is now ba...

WLF Backs Allergan Off-label Suit

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Washington Legal Foundation and three patient groups say they support Allergans challenge to FDA regulations preventing it from sh...

FDA, Genzyme Agree to Lumizyme Manufacturing Change

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Genzyme says it will ask FDA to approve manufacturing Lumizyne at a larger bioreactor scale to avoid problems at its Allston, MA, ...

Abilify Discmelt Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Abilify Discmelt orally disintegrating tablets, 20 and 30 mg were not withdrawn from ...

FDA Clears Spectranetics VisiSheath Dilator Sheath

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FDA clears a Spectranetics Corp. 510(k) for its VisiSheath Dilator device for dilating tissue surrounding cardiac leads or as an e...