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Anti-Fraud & Sunshine Update

Complaint FDA

Do you know when to report a medical device complaint?

data privacy

2022 Privacy Update

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

medical cybersecurity

FDA’s New Draft Guidance on Cybersecurity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

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Back on the Case: FDA Issues Fresh Enforcement Letters

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AdvaMed Code 2022 Updates: What you need to know.

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

Doctor,Talking,To,A,Pharmaceutical,Sales,Representative.

9 Months After Mallory: Keeping Independent Contractors Independent

Doctor,Pushing,Button,Locked,Shield,Virus,Security,Virtual,Healthcare,Network

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

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“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?

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Sunny Skies Turn Dark as Sunshine Act Enforcement Ramps

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In the Wake of the Safe Harbor Updates – Key Takeaways

Privacy-1

Privacy Update for Drug & Device Makers

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Sunshine, FDA Commissioner, & Gardner News

Regulatory

2020 Regulatory Update from Both Sides of the Pond

U.S. Department of Health & Human Services seal

OIG issues Special Fraud Alert on Speaker Programs

FDA

FDA resumes domestic inspections. Are you ready?

EU and American flags

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

medical tablet

Are you promoting products virtually in the COVID era?

Doctor wearing mask

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

FDA logo

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

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Regulatory update from both sides of the pond

How to avoid “going viral” with the FDA

Sunshine example

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?