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FDA Names Performance Review Board for Senior Officials Pay

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Federal Register Notice: FDA announces the names of the members who will serve on its Performance Review Board that will review se...

Comments Sought on Device Fellowship Program Applications

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Federal Register Notice: FDA seeks comments on an information collection extension submitted to OMB related to Applications for Pa...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Dongying Tiandong Pharmaceutical Co. and STI Pharma.

FDA Approves Lupins Generic Nuvigil

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FDA approves a Lupin Ltd. ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg generic versions of Cephalons Nuvigil, in...

FDA Priority Review for EMD Seronos Avelumab

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FDA accepts for priority review an EMD Serono BLA for avelumab and its use in patients with metastatic Merkel cell carcinoma.

Public Citizen, Others Hit FDA on Intellectual Bias Exclusions

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Public Citizen and seven other consumer and government watchdog groups tell FDA that its draft guidance on Procedures for Evaluati...

OMB Approves Information Collection on 505(b)(2) Applications

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Federal Register Notice: FDA announces that OMB has approved an information collection on Abbreviated New Drug Applications and 50...

Comments Sought on Expedited Programs Guidance Extension

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Federal Register Notice: FDA asks for comments on an information collection extension on its guidance for Expedited Programs for S...

Comments Sought on New DTC Study of Superimposed Text

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Federal Register Notice: FDA seeks comments on a new direct-to-consumer study proposal submitted to OMB for approval on Superimpos...

Guide on Mitigating Risks With Endoscope Irrigation

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FDA posts a guidance on Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexibl...