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Look at Underlying Trends in Generic Drug Prices: Gottlieb

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Former FDA deputy commissioner Scott Gottlieb calls on Congress to focus on underlying policies and trends that could lead to an o...

FDA, EMA Advance Mutual Reliance on GMP Inspections

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FDA meets with European Medicines Agency and GMP experts from EU member states to advance a mutual reliance initiative for GMP ins...

FDA Approves Kubtec Portable X-ray System for Neonates

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FDA approves a Kubtec PMA for its KUB 250, a portable low-dose digital X-ray system dedicated to the neonatal intensive care unit.

FDA Grants Fast Track for Novavax for RSV F-Protein Vaccine

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FDA grants Novavax fast track status for its RSV F-Protein nanoparticle vaccine candidate.

Groups Back FDA Drug Compounding Enforcement

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Six stakeholder groups praise FDAs risk-based approach to regulating drug compounding.

FDA Collection of Info on Risk/Benefit Perception to OMB

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Federal Register Notice: FDA submits a proposed collection of information on risk and benefit perception scale development to the ...

FDA Seeks Drug Risk/Benefit Perception Measures

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FDA proposes drug advertising research to give it a pool of measurement tools to evaluate consumer perceptions of risk and benefit...

Chemistry Question-based Review MAPP

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CDERs Office of Pharmaceutical Science issues a MAPP on using a question-based review template.

Look at FDA Role in Drug Competition: Report

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A Matrix Global Advisors report says more attention should be paid to the ways in which FDA helps and hurts drug price competition...

New Requirements for Info on ClinicalTrials.gov

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The National Institutes of Health proposes new rules on registration and summary results information from some clinical trials for...