Sorensen Discusses Compliance Considerations for Companies Entering U.S. Market

26 April 2019 Thinkset Podcast News

Of Counsel Heidi Sorensen was interviewed on the Thinkset Podcast, “Episode 24: Katie Norris and Heidi Sorensen – Commercialization Risk and Compliance,” about compliance considerations companies should factor into their strategy and planning when they are entering the U.S. market from abroad or preparing to commercialize an FDA-regulated product.

Sorensen said some of those considerations include what the company’s key compliance risks are, any payer considerations, and the applicable rules, regulations and guidance from the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, and any state regulators or licensing boards. She said the company will want to create a program that will address those risks and that the program it creates has to be scalable.

“So, having a program that can scale up as the product becomes bigger and has more of a market is very important,” she said. “And then, finally, making sure that your employees are trained and understand the goals of the compliance program and how it fits into the company’s business goals.”

Related Services

Insights

California Statute Offers Dramatic Change to Independent Contractor, Franchise-Franchisee Relationships
20 September 2019
Legal News: Distribution & Franchise
AI Ouch! AI Job Interview Law Starting in 2020!
20 September 2019
Internet, IT & e-Discovery Blog
RCE PTA Carve-Out Resumes After Interference
18 September 2019
PharmaPatents
The Ninth Circuit Expected to Rule that Doctors Can Be Wrong in the Winter v. Gardens False Claims Act Case
18 September 2019
Legal News: Government Enforcement Defense & Investigations
Lacktman, Ferrante Cited in mHealth Intelligence About Ryan Haight Act
19 September 2019
mHealth Intelligence
Vernaglia Comments on AHA v Azar Decision
18 September 2019
MedPage Today
Tinnen Discusses How Viewpoint Diversity Helps Businesses Thrive
18 September 2019
InsideTrack
Lach Comments on Launch of New Group
16 September 2019
BizTimes Milwaukee
MedTech Impact Expo & Conference
13-15 December 2019
Las Vegas, NV
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
BRG Healthcare Leadership Conference
06 December 2019
Washington, D.C.
CTeL Telehealth Fall Summit 2019
04-06 December 2019
Washington, D.C.