Ralph S. Tyler

Ralph S. Tyler

Venable LLP

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Protecting Drug Supply Chain Security

Millions of Americans take prescription drugs every day while assuming that those drugs are what they purport to be, that they have not been tampered with, and certainly that they are not counterfeit. The validity of those...more

6/13/2014 - DSCSA FDA FDCA Manufacturers Pharmaceutical Prescription Drugs Supply Chain

FDA’s Message to Medical Device Company: Stop

The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious...more

11/29/2013 - 23andMe FDA FDCA Genetic Testing Medical Devices

Advertising News & Analysis – December 13, 2012

In this issue: - It’s Easier Being Green - Off-Label Marketing Protected by First Amendment - Understanding New Restrictions on Advertising GI Bill Benefits - FTC Looks at "The Big Picture" - Upcoming...more

12/17/2012 - Advertising Commercial Speech FDA FDCA Free Speech FTC GI Bill Green Guides Marketing Off-Label Promotion Off-Label Use Pharmaceutical

Second Circuit Rules Off-Label Marketing is Protected by First Amendment

On December 3, 2012, the United States Court of Appeals for the Second Circuit, in a 2-1 opinion, vacated the criminal conviction of a pharmaceutical sales representative for promoting off-label uses of a particular drug....more

12/10/2012 - FDCA First Amendment Off-Label Promotion Pharmaceutical

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