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Analgesic onset claims to be reviewed by FDA's Arthritis Cmte., NDAC members.

This article was originally published in The Tan Sheet

Executive Summary

ANALGESIC ONSET CLAIMS TO BE DISCUSSED BY FDA's ARTHRITIS CMTE., NDAC members along with the "claim structure for chronic and acute pain," at a March 25 meeting. FDA's Arthritis Advisory Committee, with representatives from the Nonprescription Drugs Advisory Committee, will address both Rx and OTC analgesic onset claims, including "appropriate study design for prescription and nonprescription oral analgesics." On March 24, the Arthritis committee will discuss the safety of nonsteroidal anti-inflammatory drugs, including COX-2 agents, which act as anti-inflammatories through inhibition of the cyclooxygenase-2 protein and are considered to be a next generation of arthritis drugs.
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