BIO Comments on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format
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The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the <em>Draft Guidance for Industry on</em> <em>Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format</em>. BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.</p>
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Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format. BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.
BIO represents nearly 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
GENERAL COMMENTS:
BIO applauds FDA for the release of this Draft Guidance, which addresses many of the comments raised during the comment period for the 2009 draft it replaces, most notably avoiding duplication of information in different sections of the label and providing better clarity on the level of study detail in the clinical pharmacology section of the label. The Draft Guidance now allows flexibility depending on the existing data and has added more structure and details around data presentation. There are, however, several aspects of the guidance for which BIO requests additional information or clarification.
