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Sunshine

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21 Jan

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

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

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?

Silver,Spring,,Md,,Usa,11/10/2020:,Exterior,View,Of,The,Headquarters

26 Oct

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

Sunshine Reporting

30 Aug

What Changes are Proposed for the Open Payments Program?

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

07 Jun

Sunny Skies Turn Dark as Sunshine Act Enforcement Ramps

Lighthouse,In,Bodrum,Turgutreis,,Turkey

04 May

In the Wake of the Safe Harbor Updates – Key Takeaways

Privacy-1

13 Apr

Privacy Update for Drug & Device Makers

Pen on paper chart

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?

26 Jan

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

gardner_collage_web

18 Nov

Regulatory update from both sides of the pond

Sunshine example

08 Sep

Have you completed your 2019 Audit?