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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.

FDA Clears AdvaDx mecA XpressFISH Assay

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FDA clears an AdvanDx 510(k) for its new mecA XpressFISH assay for detecting methicillin-resistant and methicillin-susceptible Sta...

High-powered Lawyers Fighting LDT Proposal

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The American Clinical Laboratory Association says former solicitor general Paul Clements and Harvard law professor Lawrence Tribe ...

FDA Revises Guidance on 505(q) Citizen Petitions

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FDA posts a revised guidance on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q)of the Federal Food, D...

OIG Lists FDA Drug Safety Tasks

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The HHS Inspector General says there a number of tasks FDA needs to do to continue to ensure the safety of drugs and medical devic...

FDA, CDC Award Contract for Vaccine Adverse Event System

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FDA and the Centers for Disease Control and Prevention award SRA International an $18 million contract to support the Vaccine Adve...

Guidance on Rare Pediatric Disease Vouchers

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Federal Register Notice: FDA releases a draft guidance: Rare Pediatric Disease Priority Review Vouchers.

FDA Withdraws 14 NDAs

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Federal Register Notice: FDA withdraws approval of 14 NDAs from multiple application holders due to a failure to file annual repor...