Letters, Testimony & Comments

BIO comments on U.S. Patent & Trademark Office proposed reforms to PTAB patent invalidation proceedings.

BIO comments to the Office of Management & Budget in response to the agency’s request for information on measuring and classifying the bioeconomy for potential inclusion in the North American Industry Classification System (NAICS) and North…

Presented by Phyllis Arthur, MBA, BIO’s Senior Vice President of Infectious Disease and Emerging Science Policy.

BIO applauds FDA’s efforts to develop a plan consistent with PDUFA VII commitments and the FY23 Omnibus Bill and offers strategic recommendations.

Biotechnology Innovation Organization statement for the record to the U.S. House Committee on Small Business Subcommittee on Economic Growth, Tax, and Capital Access hearing on "American Ingenuity: Promoting Innovation Through the Tax Code…

The global IP framework has enabled lifesaving innovation and provides a reliable legal foundation for companies to voluntarily license their IP to enhance research collaborations and provide timely, equitable global access to safe and effective…

BIO joined with more than 40 groups in calling on Congress to set 2024 funding for the U.S. Codex Office at or above the 2023 level. 

In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.

BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.

BIO’s submission is in response to the USPTO’s Request for Comments (88 FR 9492, February 14, 2023)