Anticaries monograph effective date delayed until April 1997 -- FDA final rule.
This article was originally published in The Tan Sheet
Executive Summary
ANTICARIES FINAL MONOGRAPH EFFECTIVE DATE EXTENDED SIX MONTHS from Oct. 6, 1996 to April 7, 1997, according to an FDA final rule recently published in the Federal Register. The delay will allow manufacturers time to revise labeling in response to a "minor revision" of the second general warning for anticaries products, FDA explained; the revision is a "technical amendment" to the final monograph for OTC anticaries drug products. The monograph was published in October 1995 ("The Tan Sheet" Oct. 16, 1995, p. 10).
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning