Enforcement Matters at FDA
Measuring activities at the U.S. Food and Drug Administration can be challenging, given the continuous policy-based shifts and personnel changes that impact regulatory enforcement. A number of provisions in the Affordable Care Act affect FDA, adding to the changing regulatory environment that impacts the Bio/Med industry.
Torrey Cope, Senior Associate at Sidley Austin LLP believes it's fundamentally important for the FDA to be challenged. In a recent conversation, he indicated a lot of his clients are hesitant to push back on enforcement matters, particularly when they have an application pending. Sidley Austin is known globally for its good track record as the go-to authority for companies confronting FDA regulatory issues.
The FDA-TRACK website provides resources and progress updates where people can monitor a good amount of FDA's ongoing projects, and there's nothing more important than being well-informed according to Cope. He is no stranger to changes in the regulatory environment driven by government agencies and media attention. Cope will speak to MedTech members about anticipating and navigating key FDA enforcement trends on June 13 at the association's 2013 Annual Members Dinner.
MedTech's 2013 Annual Members Dinner, presented by Ortho Clinical Diagnostics, is also sponsored in part by ConMed and Welch Allyn.