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Transfer to FDA and Biological Products Review
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The retrospective biologics review also included an evaluation of product labeling, and in one quarter of 1973 alone the Bureau received nearly 500 submissions of proposed labeling from manufacturers of both licensed commodities and products awaiting licensure. Advertising, too, was part of the Bureau’s oversight, that function first assigned to FDA for prescription products under the 1962 Drug Amendments. For example, in 1973 Bureau monitoring of professional journal advertising resulted in a notice to one manufacturer for corrective changes to claims made.
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