BIO Submits Comments on Pediatrics Clinical Pharmacology
<p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.”</p>
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.”
BIO is the world's largest trade association representing 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.
BIO greatly appreciates the Agency’s work to publish this Draft Guidance. There are several aspects of the Draft Guidance for which BIO respectfully requests additional information or clarification.
