FDA Labeling Proposal Should Allow "Flexible" Warnings, Merck Tells Agency
Standardized headings in the "Warnings/Precautions" section of labeling would inappropriately limit manufacturer flexibility in communicating drug risk information, Merck said in comments on the agency's labeling rewrite proposed rule.
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FDA's prescription drug labeling initiative should proceed in areas where there is consensus between the agency and the pharmaceutical industry, the Pharmaceutical Research & Manufacturers of America said in comments on the proposed rule.
Information included in the "Highlights" summary section of drug labeling under FDA's proposed rule would likely be inconsistent from product to product, Merck said in comments on FDA's proposed labeling rule.
The new Highlights section of labeling under FDA's proposed labeling rule would feature a summary of the product's indication rather than the indication verbatim.