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.
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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.