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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On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (the Homologous...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[Medical Device Alert] Draft Guidance on General Considerations for Animal Studies Medical Device Alert

On October 14, 2015, the Food and Drug Administration (FDA) released a draft guidance document, General Considerations for Animal Studies for Medical Devices, discussing designing...

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[Medical Device Alert] DuPont's Upgraded Manufacturing Process Regarding Their Tyvek® Material and Impact on Medical Device Manufacturers Medical Device Alert

In an announcement issued by the Food and Drug Administration on October 2, 2015, the agency has determined that the performance of the new Tyvek® material is functionally equivalent to...

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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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[Environmental Alert] EPA Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals Environment Alert

On August 31, 2015, the Environmental Protection Agency issued a long-awaited proposed rule that would establish sector-specific requirements for the management of hazardous waste...

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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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