TYPE I DRUG MASTER FILES CONTINUED USE ADVOCATED BY PhRMA
Executive Summary
TYPE I DRUG MASTER FILES CONTINUED USE ADVOCATED BY PhRMA for both domestic and foreign manufacturing facilities as an efficient means of filing facility information with FDA that crosses product lines. In April 8 comments on the DMF review system, the Pharmaceutical Research & Manufacturers of America said its position "remains that there are worthwhile and justifiable reasons for filing a Type I DMF for both foreign and domestic facilities."