BIO Comments on FDA's Guidance on Consultation Procedures: Foods Derived from New Plant Varieties
February 9, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on its request for input on a public notice, Guidance on Consultation Procedures: Foods Derived from New Plant Varieties.
BIO applauds FDA’s work to develop and enforce a sensible, science-based approach to the regulation of products of agricultural biotechnology. FDA’s consultation process has worked well for nearly 30 years, and BIO members do not consider the current information requests to be unduly burdensome.
However, BIO strongly encourages the FDA to identify mechanisms to better incorporate its experience over time and, where possible, implement more efficient, streamlined review processes for products similar to ones the agency has reviewed in the past as well as products reviewed by the Center for Food Safety and Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
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) on its request for input on a public notice, Guidance on Consultation Procedures: Foods Derived from New Plant Varieties.
BIO applauds FDA’s work to develop and enforce a sensible, science-based approach to the regulation of products of agricultural biotechnology. FDA’s consultation process has worked well for nearly 30 years, and BIO members do not consider the current information requests to be unduly burdensome.
However, BIO strongly encourages the FDA to identify mechanisms to better incorporate its experience over time and, where possible, implement more efficient, streamlined review processes for products similar to ones the agency has reviewed in the past as well as products reviewed by the Center for Food Safety and Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).