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REMINDER: Sunshine Act reporting deadline is March 31, 2023


Medical Device Cybersecurity: Are you Prepared?


FDA Violations and the Park Doctrine Threat

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The Buzz on Med Device Cybersecurity

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

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Anti-Fraud & Sunshine Update

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Do you know when to report a medical device complaint?

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2022 Privacy Update


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

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FDA’s New Draft Guidance on Cybersecurity

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

Clinical Research

Clinical Research: Hot Topics and Best Practices


Back on the Case: FDA Issues Fresh Enforcement Letters

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AdvaMed Code 2022 Updates: What you need to know.


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


9 Months After Mallory: Keeping Independent Contractors Independent


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


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

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Was it something I said? Communicating before FDA approval.

Sunshine Reporting

What Changes are Proposed for the Open Payments Program?


Sunny Skies Turn Dark as Sunshine Act Enforcement Ramps


In the Wake of the Safe Harbor Updates – Key Takeaways


Privacy Update for Drug & Device Makers

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Sunshine, FDA Commissioner, & Gardner News


2020 Regulatory Update from Both Sides of the Pond

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OIG issues Special Fraud Alert on Speaker Programs


FDA resumes domestic inspections. Are you ready?

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GDPR update: Why did a European court recently invalidate the EU-US Privacy Shield?

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Are you promoting products virtually in the COVID era?

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Seeking FDA Emergency Use Authorization for a COVID-19 medical device?

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Did you miss these important 2019 FDA medical device guidance documents?


Regulatory update from both sides of the pond

How to avoid “going viral” with the FDA

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Have you completed your 2019 Audit?

2019 deadlines calendar

Are you meeting the new transparency requirements?

Does your compliance program meet the revised AdvaMed Code?