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Trio of Hill chiefs head to K Street - Vimarsana News

Trio of Hill chiefs head to K Street

Three top congressional aides have left the Hill for lobbying gigs at firms across town.

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors | Epstein Becker & Green - Vimarsana News

FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors | Epstein Becker & Green

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s...

Potential Restraints on Counterclaims Interposed in a Derivative Suit | Epstein Becker & Green - Vimarsana News

Potential Restraints on Counterclaims Interposed in a Derivative Suit | Epstein Becker & Green

Shareholders who sue derivatively on behalf of a corporation are often faced with counterclaims against them as individuals. The issue of whether such counterclaims are properly...

Third Circuit Reverses and Remands Donning and Doffing Dispute for Trial, Providing New Framework for the "Integral and Indispensable" Test | Epstein Becker & Green - Vimarsana News

Third Circuit Reverses and Remands Donning and Doffing Dispute for Trial, Providing New Framework for the "Integral and Indispensable" Test | Epstein Becker & Green

On August 16, 2023, a unanimous three-judge panel of the Third Circuit vacated and remanded a decision from the Middle District of Pennsylvania ruling that the time spent by oil-rig...

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance? | Epstein Becker & Green - Vimarsana News

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance? | Epstein Becker & Green

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance...