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FDA Approves Safety Labeling Changes for 37 Drugs

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FDA approves safety labeling changes for 37 drugs including a Boxed Warning about suicidality for Lillys Cymbalta.

Agency Pushes Back ANDA Labeling Final Rule

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FDA delays finalizing a proposed rule that would require generic drug makers to use the same process as brand drug manufacturers t...

Comments Sought on ANDA Priority Reviews for First Generics

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FDA opens a public docket requesting comments on proposed criteria for first generic ANDA submissions in order for the agency to s...

FDA Clears Aurora Spines Spinal Implant

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FDA clears an Aurora Spine Corp. 510(k) for its Zip 51, an interspinous fixation implant for spinal fusion procedures.

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FDA releases a draft guidance on Rare Pediatric Disease Priority Review Vouchers that provides information on implementing Section...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