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[Pharmaceutical and Biotechnology Alert] FDA Takes Steps to Clarify Significant Human Tissue Questions Medical Device, Pharmaceutical, and Biotechnology Alert

On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (the Homologous...

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[Medical Device Alert] Important New Steps in the Evolution of the Federal Policy for Protection of Human Subjects Pharmaceutical and Biotechnology and Medical Device Alert

On September 2, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a long-anticipated Notice of Proposed Rulemaking (NPRM) to overhaul...

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[Health Alert] 340B Program: HRSA Releases Proposed “Omnibus” or “Mega” Guidance, Which Lives Up To Its Name Health, Pharmaceutical, and Biotechnology Alert

The Health Resources and Services Administration (HRSA) yesterday released its “340B Drug Pricing Program Omnibus Guidance,” also known as the “Mega-Guidance,” in proposed form.

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[Pharmaceutical and Biotechnology Alert] May the Truth Set You Free: Amarin Prevails In Its First Amendment Case Against FDA Pharmaceutical and Biotechnology Alert

On August 7, 2015, the U.S. District Court for the Southern District of New York ruled in favor of Amarin Pharma, Inc. (Amarin) in its suit against the U.S. Food and Drug Administration...

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[Health Alert] 340B Program: HRSA Releases Proposed Rule on Calculation of the Ceiling Price and Imposition of Civil Monetary Penalties on Manufacturers Health, Pharmaceutical, and Biotechnology Alert

Today, the Health Resources and Services Administration (HRSA) released a Notice of Proposed Rulemaking (NPRM) regarding the calculation of the 340B ceiling price and the imposition of...

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[Newsletter] FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations Pharmaceutical and Biotechnology Alert

On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed rule (80 FR 6802) to amend agency regulations governing...

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[Newsletter] 340B Program: Orphan Drug Exception—A Timeline of PhRMA's Legal Challenge to HRSA's Final Rule Health, Pharmaceutical, and Biotechnology Alert

On Wednesday, August 27, 2014, the U.S. District Court for the District of Columbia entered final judgment in the legal challenge to the final rule on the treatment of orphan drugs under...

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[Newsletter] Two Draft Guidances Indicate FDA May Expand the Scope of HCT/P Products Subject to Premarket Review Medical Device and Pharmaceutical Product Alert

On December 17 and December 24, 2014, the Food and Drug Administration (FDA or the agency) published two related, human tissue-focused draft guidance documents, one on “Minimal Manipulation ...

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