Drugs, biologics, and devices are increasingly used to treat patients in ways that were not approved or cleared by FDA. While FDA does not regulate the practice of medicine or off-label use, it does regulate off-label promotion. However, the FDA has released a "reprints" guidance that permit companies, in limited circumstances, to distribute certain types of materials that discuss off-label use of the products.
Saul Ewing LLP is a sponsor of this one-hour seminar that will address this tension between patient benefit and government enforcement. The seminar will take place from 8 a.m. to 9 a.m., with a continental breakfast beginning at 7:30 a.m. The seminar will take place in the Fuller Conference Room at the University City Science Center, 3711 Market Street in Philadelphia, PA.
Mark C. Levy, Co-Chair of the Life Sciences Practice Group, along with Virginia Gibson, First Assistant U.S. Attorney for the Eastern District of Pennsylvania, will present the seminar.
To view a PDF of the materials for this program, click here.