Entreprise · 13/02/19981 min de lecture
Over-the-Counter Human Drugs; Proposed Labeling Requirements; Notice of Availability of Study Data and Reopening of Comment Period
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Résumé
The Food and Drug Administration (FDA) is reopening to March 30, 1998 the comment period on specific data related to the February 27, 1997, proposed rule to establish a standardized format for the labeling of over-the-counter (OTC) drug products (62 FR 9024). As part of that rulemaking proceeding, the agency collected data under a study entitled ``Evaluation of Proposed Over-the-Counter (OTC) Label Format Comprehension,'' (Study A). This document announces the availability of the data and frequency tabulations that summarize the Study A data and reopens the comment period for the OTC rulemaking proceeding to allow an opportunity for comment on Study A.