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FDA Sets Tropic Disease Priority Review Rates

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Federal Register Notice: FDA announces the fee rates for using a tropical disease priority review voucher for fiscal year 2015.

FDA Corrects Notice on Outsourcing Facility Fees

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Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the FY 2015 fees for human drug comp...

Info on Drug Compounding Facility Guidance Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

Guidance on Generic Drug Development Correspondence with FDA

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Federal Register Notice: FDA releases a draft guidance: Controlled Correspondence Related to Generic Drug Development.

Guidance on Multiplexed In Vitro Nucleic Acid Diagnostics

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Federal Register Notice: FDA releases a guidance, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid ...

Amarin Asks Specific Vascepa BE Testing

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Amarin petitions FDA to require specific bioequivalence testing for ANDA citing Vascepa as the reference-listed drug.

ISPE Announces Drug Shortage Prevention Plan

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The International Society for Pharmaceutical Engineering says it has a six-dimension plan to help avoid drug shortages.

Researchers Build an Open ADE Resource

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Researchers describe their effort to normalize data in the FDA Adverse Event Reporting System to make it more useful for data mini...

Celebrities in Drug Ads May Not be Influential

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Pharmafile says research shows that using celebrities in drug ads doesnt lead to consumer action to get a prescription.

Aegerion Resolves OPDP Warning Letter Citations

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CDERs Office of Prescription Drug Promotion issues Aegerion Pharmaceuticals a close-out letter indicating the firms resolution of ...