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ニュースレター等
04 11月 2015
On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (the Homologous...
ニュースレター等
19 10月 2015
On October 14, 2015, the Food and Drug Administration (FDA) released a draft guidance document, General Considerations for Animal Studies for Medical Devices, discussing designing...
ニュースレター等
7 October 2015
The Court of Justice of the European Union declares invalid the European Commission's Safe Harbor Decision and its implications on the transfer of clinical data to the U.S
ニュースレター等
05 10月 2015
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...
ニュースレター等
22/09/2015
The Economic Committee for Healthcare Products (CEPS) – which is notably in charge of setting up the economic policy and policy for proper use of medicines (Article L. 162-17-3 of the...
ニュースレター等
14 9月 2015
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...
ニュースレター等
28 8月 2015
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.
ニュースレター等
19 8月 2015
A federal court recently issued a decision in the first case addressing a pivotal area of interest for healthcare providers following enactment of the “60-day rule” under the Affordable...
