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23 Feb

REMINDER: Sunshine Act reporting deadline is March 31, 2023

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14 Feb

Medical Device Cybersecurity: Are you Prepared?

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24 Jan

FDA Violations and the Park Doctrine Threat

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19 Dec

The Buzz on Med Device Cybersecurity

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20 Oct

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

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26 Sep

Anti-Fraud & Sunshine Update

Complaint FDA
14 Sep

Do you know when to report a medical device complaint?

data privacy
06 Sep

2022 Privacy Update

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23 Aug

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

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16 Aug

FDA’s New Draft Guidance on Cybersecurity

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08 Aug

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

Clinical Research
27 Jul

Clinical Research: Hot Topics and Best Practices

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11 Jul

Back on the Case: FDA Issues Fresh Enforcement Letters

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28 Apr

AdvaMed Code 2022 Updates: What you need to know.

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25 Jan

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

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13 Dec

9 Months After Mallory: Keeping Independent Contractors Independent

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

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

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26 Oct

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

Two mature smiling doctors having discussion about patient diagnosis, holding digital tablet. Representative pharmaceutical discussing case after positive result with happy doctor about new medicine.
04 Oct

Was it something I said? Communicating before FDA approval.

Sunshine Reporting
30 Aug

What Changes are Proposed for the Open Payments Program?

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07 Jun

Sunny Skies Turn Dark as Sunshine Act Enforcement Ramps

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04 May

In the Wake of the Safe Harbor Updates – Key Takeaways

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13 Apr

Privacy Update for Drug & Device Makers

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24 Mar

Sunshine, FDA Commissioner, & Gardner News

Regulatory
03 Dec

2020 Regulatory Update from Both Sides of the Pond

U.S. Department of Health & Human Services seal
23 Nov

OIG issues Special Fraud Alert on Speaker Programs

FDA
29 Sep

FDA resumes domestic inspections. Are you ready?

EU and American flags
25 Aug

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

medical tablet
30 Jul

Are you promoting products virtually in the COVID era?

Doctor wearing mask
22 Apr

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

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26 Jan

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

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18 Nov

Regulatory update from both sides of the pond

15 Oct

How to avoid “going viral” with the FDA

Sunshine example
08 Sep

Have you completed your 2019 Audit?

2019 deadlines calendar
01 Jul

Are you meeting the new transparency requirements?

22 Jun

Does your compliance program meet the revised AdvaMed Code?