Author: admin

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[…]

EBA Guidelines on Internal Governance

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In the European Banking Authority’s (EBA) new Guidelines on Internal Governance the aim is to enhance and consolidate supervisory expectations and improve the implementation of internal governance arrangements for individual institutions and the banking system as a whole It has 6 key sections . 1 -Corporate Structure and Organization The management body should ensure that Read more about EBA Guidelines on Internal Governance[…]

Guidance on pulse oximeter applications

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March 4 2013, The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance,  the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the Read more about Guidance on pulse oximeter applications[…]

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[…]

Virtual currencies, gold, money laundering, regulations etc

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Now EU is mulling ban on virtual currencies and particularly bit coins as it seems there are more chances of irregularities which might happen and antisocial elements can use this route to beat the current regulations. “It’s imperative to move quickly on this issue,” Chantal Hughes, a spokeswoman for Financial Services Commissioner Michel Barnier, said Read more about Virtual currencies, gold, money laundering, regulations etc[…]

Complying With FLSA Requirements

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The Fair Labor Standards Act (FLSA) of 1938 is key piece of compensation legislation. Although FLSA has been around for a long time, it is the most frequently violated employment law.  Employers misclassify employees as exempt or fail to calculate working time accurately. Misclassifications can result in severe back pay issues. Calculating overtime incorrectly can often result Read more about Complying With FLSA Requirements[…]

U.S. Export/Sanctions Laws

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There are three primary set of export and sanctions rules. These are: U.S. Export Administration Regulations (EAR) International Traffic in Arms Regulations (ITAR) Economic Sanctions Regulations U.S. Export Administration Regulations Export Administration Regulations (EAR) are found in 15 CFR Parts 730 to 744. These are administered under International Economic Emergency Powers Act by the Commerce Read more about U.S. Export/Sanctions Laws[…]

Export Administration Regulations

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Over the last several years, the regulatory framework for export controls and economic sanctions in the U.S. has undergone significant changes. At the same time the risk of enforcement in the event of non-compliance has grown.Most products and technologies contemplated for export from the U.S. fall under the requirements of the Export Administration Regulations EAR. Read more about Export Administration Regulations[…]