BIO Comments on FDA's Review of Existing General Regulatory and Information Collection Requirements
February 5, 2017
BIO submitted comments to the Food and Drug Administration (FDA) request for public input on a notice, Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration, along with comments on several other Center-specific notices. The comments related to the Center for Biologics Evaluation and Research CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM).
The comments cover the consultation process for foods derived from new plant varieties, review of genetically engineered animals containing heritable recombinant DNA constructs, experience with genetically engineered animals regulated as new animal drugs, labeling of these products, and food additives.
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee…
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000…
BIO submitted comments to the Food and Drug Administration (FDA) request for public input on a notice, Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration, along with comments on several other Center-specific notices. The comments related to the Center for Biologics Evaluation and Research CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM).
The comments cover the consultation process for foods derived from new plant varieties, review of genetically engineered animals containing heritable recombinant DNA constructs, experience with genetically engineered animals regulated as new animal drugs, labeling of these products, and food additives.