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On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (the Homologous...


[Medical Device Alert] Draft Guidance on General Considerations for Animal Studies Medical Device Alert

On October 14, 2015, the Food and Drug Administration (FDA) released a draft guidance document, General Considerations for Animal Studies for Medical Devices, discussing designing...


[Newsletter] European Court invalidates transfer of clinical data from the EU to the U.S through the Safe Harbor Framework

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


[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...


[Newsletter] CEPS publishes its annual report 2014/2015

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...


[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...


[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.


[Health Alert] Gone in 60-days? Not So Fast - Federal Court Emphasizes Corrective Action in 60-Day Overpayments Case Health Alert

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...

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