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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.

Was it something I said? Communicating before FDA approval.

Sunshine Reporting

What Changes are Proposed for the Open Payments Program?

Regulatory,Compliance,Concept,On,The,Gearwheels,,3d,Rendering

Sunny Skies Turn Dark as Sunshine Act Enforcement Ramps

Lighthouse,In,Bodrum,Turgutreis,,Turkey

In the Wake of the Safe Harbor Updates – Key Takeaways

Privacy-1

Privacy Update for Drug & Device Makers

Pen on paper chart

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?

gardner_collage_web

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?