FDA's NDAC shuffle
This article was originally published in The Tan Sheet
Executive Summary
Late July meeting reduced to one day from three. NDAC will not meet July 27 or 28, as previously scheduled, but only on July 29 at the Bethesda Holiday Inn ("The Tan Sheet" March 2, p. 5). The topic for that day remains the same -- effectiveness testing for final formulations of antiseptic health care products under the Health Care Continuum Model, with the public hearing portion set for 1-2 p.m. The proposed topic for the next scheduled meeting on Sept. 11, pediatric labeling for combination drug products, now has been displaced by a discussion of FDA's OTC vaginal yeast infection draft guidance discussion. Pediatric labeling will be rescheduled...
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Late July meeting reduced to one day from three. NDAC will not meet July 27 or 28, as previously scheduled, but only on July 29 at the Bethesda Holiday Inn ("The Tan Sheet" March 2, p. 5). The topic for that day remains the same -- effectiveness testing for final formulations of antiseptic health care products under the Health Care Continuum Model, with the public hearing portion set for 1-2 p.m. The proposed topic for the next scheduled meeting on Sept. 11, pediatric labeling for combination drug products, now has been displaced by a discussion of FDA's OTC vaginal yeast infection draft guidance discussion. Pediatric labeling will be rescheduled.... |