The US Nonprescription Drug Manufacturers Association has said it needsmore time to review proposed over-the-counter drug labeling as put forward by the Food and Drug Administration, and has asked the agency to extend the period for comment by 90 days, to September 25.
Labeling rules as proposed (Marketletters passim), the NDMA told the FDA, will have more universal impact on OTCs than any rule published in the past 20 years. While many of the proposals appear to have the potential for significant economic and perhaps environmental impact, the NDMA stresses its need to comment in a meaningful way. The association is consulting with drugmakers to determine the actual costs and the time involved in major label revisions.
In addition, the NDMA has said it is filing a statement with the Senate Labor and Human Resources Committee calling for a statutory provision, requiring national uniformity in OTC drugs regulation.
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NDMA Wants More Time To Comment On OTC Labeling
The US Nonprescription Drug Manufacturers Association has said it needsmore time to review proposed over-the-counter drug labeling as put forward by the Food and Drug Administration, and has asked the agency to extend the period for comment by 90 days, to September 25.
Labeling rules as proposed (Marketletters passim), the NDMA told the FDA, will have more universal impact on OTCs than any rule published in the past 20 years. While many of the proposals appear to have the potential for significant economic and perhaps environmental impact, the NDMA stresses its need to comment in a meaningful way. The association is consulting with drugmakers to determine the actual costs and the time involved in major label revisions.
In addition, the NDMA has said it is filing a statement with the Senate Labor and Human Resources Committee calling for a statutory provision, requiring national uniformity in OTC drugs regulation.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
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