OTC drug reg
This article was originally published in The Rose Sheet
Executive Summary
CTFA requests additional one-year extension to FDA's OTC drug labeling reg in Sept. 18 letter to the agency. "More than one additional year is necessary to resolve all the issues related to this regulation in order to make compliance feasible and to permit sufficient time to comply," the trade group says. CHPA made a similar case in same-day comments (1"The Rose Sheet" Sept. 25, In Brief). FDA extended the labeling reg's 2001 deadline to May 16, 2002 in response to trade associations' October 1999 citizen petition requesting a two-year stay (2"The Rose Sheet" Feb. 14, p. 3). "The fact that almost one year has passed since filing of the CTFA and CHPA citizen petition with little progress strengthens this position," the association maintains
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CTFA requests additional one-year extension to FDA's OTC drug labeling reg in Sept. 18 letter to the agency. "More than one additional year is necessary to resolve all the issues related to this regulation in order to make compliance feasible and to permit sufficient time to comply," the trade group says. CHPA made a similar case in same-day comments (1 (Also see "OTC labeling reg" - HBW Insight, 25 Sep, 2000.)). FDA extended the labeling reg's 2001 deadline to May 16, 2002 in response to trade associations' October 1999 citizen petition requesting a two-year stay (2 (Also see "OTC Drug Labeling Implementation Date Extended One Year To 2002" - HBW Insight, 14 Feb, 2000.)). "The fact that almost one year has passed since filing of the CTFA and CHPA citizen petition with little progress strengthens this position," the association maintains. |