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.
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
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.