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 Colleagues, I am just past the two-year mark as BIO’s President & CEO, which arrives as we find ourselves at a defining moment for the future of biotechnology. For fifty years, our industry has delivered one of the great…
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.