Paragraph IV certification should include acknowledgment form -- Bristol comments to FDA.
Executive Summary
PARAGRAPH IV CERTIFICATION SHOULD INCLUDE ACKNOWLEDGMENT FORM, BRISTOL says in July 28 comments to FDA. The Bristol-Myers Squibb comments respond to a Feb. 7 citizen petition filed by the National Pharmaceutical Alliance requesting that generic drug applicants be able to notify patent and NDA holders of their intention to seek approval for a generic version of a drug prior to patent expiration via commercial delivery systems other than registered or certified mail.