Downloading Confusion: Are Mobile Drug Dose Calculators Medical Devices?
Biopharmaceutical companies are expressing concern that a recent FDA draft guidance on mobile applications could force drug firms offering apps such as drug dose calculators to register and be regulated as medical device manufacturers.
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The Institute of Medicine offers a series of recommendations to HHS to enhance the agency’s oversight of health IT, and calls on the private sector to be more engaged in sharing safety data with both the public and private sectors.
The medical device and software industries voiced support last week for a July 19 FDA draft guidance that helps clarify the types of mobile software applications that would face FDA regulation.
FDA Social Media Group Reviewing Its First iPhone App As DTC Marketing Tool, But It's Not The First To Be Released
FDA has started wading into the iPhone business, at least to help determine how drug companies can use the App Store. FDA's social media working group is reviewing its first submission for an iPhone app as a direct-to-consumer marketing tool, Division of Drug Marketing, Advertising and Communications special assistant Jean-Ah Kang told the DTC National Conference April 9