Robinson Bradshaw

Topic: mHealth

House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming

Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th). The hearings, convened jointly by several subcommittees of […]

The FDA, Social Media & Consumer Genomics: A Lot Not to “Like”

Last week, the FDA published on its website a warning letter to AMARC Enterprises, Inc., a marketer of a dietary supplement known as Poly-MVA. (Here is the company’s description of the supplement.) While the letter is not addressed to a high-profile company or product, given that the FDA’s action will likely have broader significance beyond just […]

mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the […]