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.
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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.