Paul W. Shaw

Paul W. Shaw

K&L Gates LLP

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Office of Management and Budget Releases New “Omni-Circular” Uniform Administrative Requirements, Cost Principles, and Audit...

On December 26, 2013, the Office of Management and Budget (“OMB”) released a comprehensive guidance that makes changes to the fragmented existing guidance on Administrative Requirements, Cost Principles, and Audit...more

3/19/2014 - Audits Federal Grants NFEs OMB Presidential Directives

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

12/17/2012 - FDA FDCA First Amendment Marketing Misbranding Off-Label Promotion Off-Label Use Pharmaceutical

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