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Plan B Group to Reopen Lawsuit Against FDA

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The Center for Reproductive Rights says it will reopen a 2005 lawsuit against FDA for maintaining unnecessary age restrictions on ...

Safety Labeling Changes Approved for 48 Drugs

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FDA releases safety labeling changes approved in November for 48 drug products, including a new Warning and Precaution for 11 HIV/...

Repros Meets with FDA on Testosterone Drug Study

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Repros Therapeutics says it met with CDER Divisions of Urologic and Endocrinologic Products to gain input on designing a Phase 3 t...

ViroPharma Claims Vancocin Exclusivity

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ViroPharma says FDA approval of a sNDA for new labeling information for its Vancocin meets agency requirements for three years of ...

Salix Files NDA for HIV Diarrhea Drug

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Salix Pharmaceuticals submits an NDA to FDA for crofelemer, indicated for treating HIV-associated diarrhea.

FDA OKs Dako Breast Cancer Test Kit

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FDA approves Dakos HER2 CISH pharmDx Kit as an aid in assessing breast cancer patients for whom Herceptin is being considered.

Sebelius Action Shows HHS-FDA Relations to be Opaque

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FDA Webview editor Jim Dickinson reviews FDAs opaque relationships with HHS as shown in the aftermath of the Sebelius Plan B decis...

FDA Reports Conflicting SSRI Risk Studies

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FDA says that conflicting results in new studies make it premature to reach a conclusion about a possible link between SSRI antide...

Vertex, Alios Open Hepatitis C trials

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Vertex and Alios say they are starting Phase 1 trials of two nucleotide analogs to determine their safety and tolerability for pot...

FDA Denies Plan B Petition Again

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FDA again denies a 2006 citizen petition from the Center for Reproductive Rights that seeks over-the-counter (OTC) status for the...