Category: Life Sciences & Healthcare Training

California Hazardous Waste Regulations

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California has unique hazardous waste regulations that include, but substantially exceed requirements of the federal Resource Conservation and Recovery Act (RCRA) regulations generally in effect in other states. It is also hard to navigate California’s hazardous waste requirements because of the dramatic differences in substantive requirements, enforced by pervasive local city and county agencies deputized Read more about California Hazardous Waste Regulations[…]

FTC Online Ad Guidance – what will FDA do ?

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Yesterday FTC has come up with a set of guidelines for online advertising aiming in particular,  to address the myriad questions surrounding the use of such tools as Twitter and Facebook to promote products and disseminate messages.The key question is , FDA going to follow it, copy it if yes to what extent. The various Read more about FTC Online Ad Guidance – what will FDA do ?[…]

FDA Proposes New Rule for Acceptance of Data from Clinical Studies for Medical Devices

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The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. The proposed regulation would require that clinical studies conducted outside the United States in support of an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a Read more about FDA Proposes New Rule for Acceptance of Data from Clinical Studies for Medical Devices[…]