The U.S. Food and Drug Administration warns Institut Biochimique SA that the Facebook Web page for one of its drugs is false or misleading “because it makes representations about the efficacy of Tirosint, but fails to communicate any risk information associated with its use and it omits material facts.”
The U.S. Food and Drug Administration issues revised draft guidance titled “Distributing scientific and Medical Publications on unapproved New uses—Recommended Practices” to provide the agency’s “current thinking on recommended practices for drug or medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines . . . that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the united states.” Comments are requested by May 2, 2014.
The U.S. Food and Drug Administration seeks comments on draft guidance titled “Humanitarian Device exemption (HDe): Questions and Answers.”This guidance document “reflects the changes in the HDe program” under the Food and Drug Administration safety and Innovation Act, which, among other matters, expanded the types of humanitarian use devices that are eligible to be sold for profit, subject to certain restrictions. Comments are requested by June 16, 2014.
The U.S. Patent and Trademark Office (USPTO) plans to host an “Additive Manufacturing Partnership Meeting” on April 9, 2014, in Alexandria, Virginia. A forum for sharing ideas, experiences and insights among shareholders and usPTO, this informal meeting will also provide an overview of additive manufacturing’s (also known as 3D printing’s) use in fields ranging from engineering, aerospace and the dental and medical industries.