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Public Docket on First Generic ANDA Submissions

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Federal Register Notice: FDA opens a public docket on its proposed criteria for first generic ANDA submissions.

Comments Sought on Tobacco Product Studies

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Federal Register Notice: FDA seeks comments on consumer studies on perceptions of modified risk tobacco products.

CDER Releases SDTM Validation Rules

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Federal Register Notice: CDER is making available: Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.

Guidance on Vaginal Microbicides for HIV

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Federal Register Notice: FDA is releasing a guidance: Vaginal Microbicides: Development for the Prevention of HIV Infection.

Ranbaxy Fights Loss of Tentative Approvals

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Attorney Kurt Karst says Ranbaxy has told a DC federal court that FDA does not have the right to strip the company of two tentativ...

Hamburg Building Stronger Ties on Trip to China

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FDA commissioner Margaret Hamburg meets with Chinese officials this week in China to discuss additional ways in which the two nati...

Guidance on Rare Pediatric Disease Priority Review Vouchers

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FDA releases a draft guidance on Rare Pediatric Disease Priority Review Vouchers that provides information on implementing Section...

Developing a New Drug Costs $2.6 Billion: Tufts

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A Tufts Center for the Study of Drug Development analyses says the cost of developing an approved new drug has increased to $2.6 b...

Wells Pharmacy Network Warned About Multiple Violations

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FDAs Florida District Office warns Wells Pharmacy Network about drug compounding and other violations.

QS Violations Found at MKL Diagnostics

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FDA warns Swedens MKL Diagnostics about Quality System violations in its production of diagnostic tests.