FDA to Conduct Public Hearings on Off-Label Communications

The U.S. Food and Drug Administration has announced plans to conduct a public hearing next month to obtain input on issues relating to the dissemination of information by manufacturers about the use of off-label medications. While the FDA’s job is to regulate how drug and device makers communicate about their products through approved labels, many […]

FDA issues new guidance on when medical device manufacturers should submit a 510(k)

Technology is evolving at a rapid rate, allowing medical device manufacturers to make changes and upgrades that result in improved products. But at what point in the upgrade of an existing device is approval needed from the U.S. Food and Drug Administration? That’s a question the FDA is looking to answer with the issuance of […]

Federal prosecutors increasingly target individual healthcare execs in anti-fraud efforts

Last month’s sentencing of the former president and CEO of OtisMed Corporation to two years in prison should serve as yet another example that federal prosecutors are not holding back when it comes to holding corporate executives accountable. Charlie Chi was sentenced for intentionally distributing a medical device used in knee replacement surgery despite the […]

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