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REMINDER: Sunshine Act reporting deadline is March 31, 2023

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Article | February 14, 2023

Medical Device Cybersecurity: Are you Prepared?

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Article | January 24, 2023

FDA Violations and the Park Doctrine Threat

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Article | December 19, 2022

The Buzz on Med Device Cybersecurity

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Article | October 20, 2022

What’s On the Radar of In-House Attorneys?

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Article | September 26, 2022

Anti-Fraud & Sunshine Update

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Article | September 14, 2022

Do you know when to report a medical device complaint?

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Article | September 06, 2022

2022 Privacy Update

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Article | August 23, 2022

Are you Ready for Inspection? Best Practices to “Survive” FDA Inspections

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Article | August 16, 2022

FDA’s New Draft Guidance on Cybersecurity

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Article | August 08, 2022

Are you Submission Ready? FDA Medical Device Submission Tips & Tricks

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Article | July 27, 2022

Clinical Research: Hot Topics and Best Practices

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Article | July 11, 2022

Back on the Case: FDA Issues Fresh Enforcement Letters

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Article | April 28, 2022

AdvaMed Code 2022 Updates: What you need to know.

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Article | January 25, 2022

Wishful Thinking by FDA that COVID-19 May Be Coming to an End?

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Article | December 13, 2021

9 Months After Mallory: Keeping Independent Contractors Independent

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Article | December 01, 2021

Are drug and device makers with weak cybersecurity violating the False Claims Act?

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Article | October 27, 2021

“The Long and Winding Road that Leads”… Back to Where We Started? FDA Amends its Intended Use Regulations

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Article | October 04, 2021

Was it something I said? Communicating before FDA approval.

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Article | August 30, 2021

What Changes are Proposed for the Open Payments Program?

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Article | June 07, 2021

Sunny Skies Turn Dark as Sunshine Act Enforcement Ramps

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Article | May 05, 2021

In the Wake of the Safe Harbor Updates - Key Takeaways

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Article | April 13, 2021

Privacy Update for Drug & Device Makers

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Article | March 24, 2021

Sunshine, FDA Commissioner, & Gardner News

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