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Regulatory

2020 Regulatory Update from Both Sides of the Pond

U.S. Department of Health & Human Services seal

November 2020: OIG issues Special Fraud Alert on Speaker Programs

U.S. FDA logo

September 2020: FDA resumes domestic inspections. Are you ready?

EU and American flags

August 2020: GDPR update: Why did a European court recently invalidate the EU-US Privacy Shield?

medical tablet

July 2020: Are you promoting products virtually in the COVID era?

Doctor wearing mask

April 2020: Seeking FDA Emergency Use Authorization for a COVID-19 medical device?

FDA logo

January 2020: Did you miss these important 2019 FDA medical device guidance documents?

gardner_collage_web

November 2019: Regulatory update from both sides of the pond

October 2019: How to avoid “going viral” with the FDA

Sunshine example

September 2019 Alert: Have you completed your 2019 Audit?

2019 deadlines calendar

July 2019 Alert: Are you meeting the new transparency requirements?

Does your compliance program meet the revised AdvaMed Code?