Today, BIO submitted comments to the World Health Organization (WHO) regarding its revised, draft white paper on the regulation of Cell and Gene Therapy Products (CGTPs). As stated previously, BIO emphasized that this paper represents a major milestone and will be the first global regulatory…
Letters, Testimony & Comments | October 11, 2022 | Tax
Nearly 400 companies and trade associations wrote House and Senate leaders about the need to reverse a harmful tax change--a new requirement to amortize R&D expenses--that threatens jobs and innovation.
Letters, Testimony & Comments | November 14, 2022 | Agriculture & Environment, Food & Farm Innovation, Plant Biotechnology, Farm Bill
BIO submitted a statement for the record to the Senate Committee on Agriculture, Nutrition and Forestry hearing titled "Farm Bill 2023: Rural Development and Energy Programs." BIO called for a "farm bill centered on innovation" to incentivize cutting-edge technologies and practices.
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of specific line edits, BIO suggested broadly that the ICH…
Letters, Testimony & Comments | April 14, 2023 | Medicaid
BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.
Letters, Testimony & Comments | May 5, 2023 | COVID-19
In this Post-hearing Supplementary Written Submission, BIO submits a 500-word summary of our position on the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.
Letters, Testimony & Comments | May 5, 2023 | COVID-19
In this Post-hearing Supplementary Written Submission, BIO submits detailed comments to support the USITC investigation into the proposed WTO IP Waiver for COVID-19 therapeutics.