Robinson Bradshaw

Month: March 2013

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 […]