Letters, Testimony & Comments

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the Draft Guidance on Rare Diseases: Common Issues in Drug Development. BIO is the world’s largest trade…

April 2, 2019 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2018-D-4628-0001: REMS Assessment: Planning and Reporting Dear Sir/Madam, The Biotechnology…

One area where the guideline is of particular relevance to BIO, and is thus appreciated, is in establishing both clarity and flexibility around the need and value of studies conducted in nonhuman primates. The language in Section 3.3 that…

Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access…

The Biotechnology Innovation Organization (BIO) responded to the SEC’s request for comments on the nature and timing of disclosures that reporting companies are required to provide in their quarterly reports. BIO believes that the current quarterly…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. In the comments, BIO thanks FDA for promoting partnership between patients,…

BIO supports CMS’ commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment,…

On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Biomarker Qualification: Evidentiary Framework. The guidance provides industry and FDA staff with recommendations on considerations to address when developing a…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Framework for a Real-World Evidence Program. As required by the 21st Century Cures Act, FDA created this framework for evaluating the potential use of Real-World…