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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Clinical Pharmacology & Therapeutics , 111(3), 531538. Pharmaceutical Regulations in Japan 2020. Journal of Clinical Pharmacology , 51(3), 531538. Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis. Freyr Solutions.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

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Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FDA on April 28, 2011 and by the European Commission on September 7, 2011. in 2011, ZYTIGA ® has been approved in combination with prednisone or prednisolone, in more than 100 countries. Additionally, ZYTIGA ® was approved for the treatment of high-risk mCSPC by the European Commission on November 20, 2017 and by the U.S.