Regulatory Affairs Professionals Society

Executive Summary

Keynote speaker at RAPS' annual meeting Sept. 13-14 in Washington is FDA Deputy Com. Novitch, who will speak on the development of agency action plans for the next decade and beyond. "Regulatory Perspectives" panel moderated by D.C. attorney James Phelps will include six officials from the agency's Centers for Drugs & Biologics and for Devices & Radiological Health. Workshop on ANDA/Patent Restoration bill will feature Milton Bass (Bass Ullman & Lustigman); PMA counsel Neil Mulcahy; and Natl. Assn. of Pharmaceutical Mfrs. Exec Director George Schwartz