Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was featured in a blog segment titled “More Mobile Health App Guidance from FDA for Pharma to Worry About.”
Following is an excerpt:
I interviewed Bradley Merrill Thompson, Member of the Firm at Epstein Becker Green and General Counsel to the mHealth Regulatory Coalition. We discussed the prospects for FDA’s final guidance on regulation of mobile medical apps (MMAs) and other regulatory issues that the mobile health community and FDA will need to face after publication of the “final” guidelines. In his closing remarks, however, Thompson revealed that there is ANOTHER FDA mobile guidance that the drug industry should be concerned about: new guidelines regarding FDA’s regulation of clinical decision support (CDS) software.