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FDA Actions Led to Avastin Compounding Ban

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Genentech says FDA concerns caused it to decide not to continue supplying Avastin to compounding pharmacies.

FDA Approvable Letter on Mucinex with Codeine

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FDA sends Adams Respiratory Therapeutics an approvable letter on its NDA for Mucinex with codeine, which is indicated for treating...

First Xenotransplantation Device Approved

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FDA approves a Genzyme humanitarian device exemption application for Epicel (cultured epidermal autografts), indicated for treatin...

FDA Requires New Certification for Petitions

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FDA begins turning away citizen petitions that do not include an FDA Amendments Act mandated certification for those seeking poten...

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Federal Register Notice: FDA releases a draft guidance on blood establishment computer system validation in the users facility.