In Brief: NDMA briefing
This article was originally published in The Tan Sheet
Executive Summary
NDMA briefing: The Nonprescription Drug Manufacturers Association will hold a Dec. 3 briefing on the FDA reform bills recently passed in the House and Senate. The bills are awaiting discussion in conference before being forwarded to the President. The focus of the meeting will be on the national uniformity and OTC records inspection provisions in the legislation. FDA District Director New Jersey District Douglas Ellsworth is tentatively scheduled to speak. Other speakers will include McNeil Consumer Products Director of Contract Operations and New Business Donald Cadge and Bruce Cuhlik, Covington & Burling. FDA has indicated the increased inspection authorities authorized under the bill would significantly alter its approach to OTC inspections ("The Tan Sheet" Oct. 20, p. 25). The meeting will be held at the Newark, N.J. Airport Marriott and is scheduled to run from 9 a.m. to 1 p.m. A closed session, involving industry participants only, will start at 11 a.m...