Quality

To receive these alerts in your inbox, please provide your email address:

All
  • All
  • Ad Promo Review
  • Clinical
  • Compliance
  • Enforcement
  • Privacy
  • Quality
  • Regulatory
  • Sunshine
shutterstock_1927938266
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

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?

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?

FDA logo
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

15 Oct

How to avoid “going viral” with the FDA

Sunshine example
08 Sep

Have you completed your 2019 Audit?