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Edwards Wants DTC Drug Ad Pre-Approval

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Democratic presidential hopeful John Edwards wants to reform drug DTC advertising, including requiring FDA prior approval for all ...

Senators Bill Would Kill Drug Market Exclusivity

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Sen. Bernie Sanders introduces legislation to abolish Waxman-Hatch and other patent and market exclusivity provisions and replace ...

Protherics Recalls One Lot of CroFab

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FDA says Protherics has recalled one lot of its pit viper antivenin CroFab due to a sub-potency concern.

Jerini Submits NDA for Icatibant

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Jerini AG submits an NDA for Icatibant, indicated for treating hereditary angioedema.

Takeda Faces Set Back with Cholesterol Drug

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FDA requests additional clinical testing from Takeda before it will accept an NDA for its cholesterol drug TAK-475 due to adverse ...

Guidance on Blood Establishment Computer Validation

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Federal Register Notice: FDA releases a draft guidance on blood establishment computer system validation in the users facility.

Guidance on DNA Vaccines Development

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Federal Register Notice: FDA releases a guidance on considerations for plasmid DNA vaccines for infectious diseases.

Drugs Elderly Impact Missed: GAO

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GAO says FDA does not make clear to medical reviewers that they should assess NDA trial data for representation of elderly people ...

Grassley Wants FDA Safety Oversight Transparency

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Sen. Chuck Grassley asks FDA commissioner Andrew von Eschenbach about reports the agency Drug Safety Oversight Board voted 8-7 to ...

Guidance on Advisors Financial Information

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FDA issues a draft guidance on collecting and disseminating financial interest information from advisory committee members.