Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “Hosting and Managing User Generated Content (UGC)” on Thursday, January 19, 2017 at 12 p.m. ET. This webinar will address the legal liability and responsibility of a drug or device company that incorporating any user generated content (UGC) features on websites … Continue Reading
On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance addresses conditions under which the FDA does not intend to take action for violations of 505, 502(f)(1) and 501(a)(2)(B) of … Continue Reading
The Ninth Circuit recently confronted an issue of first impression: whether a plaintiff could maintain an action under the false advertising prong of the Lanham Act, where a determination of the alleged falsity would require the court to impinge on the exclusive purview of the Food and Drug Administration (FDA) in deciding whether there has been a violation of the Food, Drug, and Cosmetic Act (FDCA). Although limited to the particular circumstances presented, the opinion reaffirmed the exclusive authority of the FDA to enforce the provisions of the FDCA, and indicates that a plaintiff may not maintain a lawsuit premised on the allegation of a violation of the FDCA, where the FDA itself has not acted.… Continue Reading
