Rolaids labeling deferral
This article was originally published in The Tan Sheet
Executive Summary
Pfizer asks FDA for seven-month extension of May 16 "Drug Facts" labeling compliance deadline for convenience roll packages of regular, extra strength Rolaids. Additional time is necessary "to ensure...we can acquire, install and validate the equipment that is necessary to produce, on a reliable, repetitive basis, a 'compliant' roll package," Feb. 27 submission states. Pfizer cites Lil' Drug Store Products' petition for an industry-wide labeling deferral for convenience-size packages; FDA responded to the petition in January, saying a notice delaying the compliance date for such packages would be published in an upcoming Federal Register notice (1"The Tan Sheet" Feb. 4, 2002, p. 5)...
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Rolaids labeling deferral
FDA grants Pfizer's request for seven-month extension of May 16 "Drug Facts" labeling compliance deadline for convenience roll packages of regular, extra-strength Rolaids, according to April 15 letter. Deferral was granted so firm can have additional time to "acquire, install and validate" equipment necessary to produce a compliant roll package (1"The Tan Sheet" March 18, 2002, In Brief)...
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