Close

The Economic Contribution of University/Nonprofit Inventions in the United States: 1996-2017

Jun 5 2019

Rare Diseases: BIO Comments on FDA Draft Guidance Rare Diseases: Natural History Studies for Drug Development

May 24 2019
BIO appreciates the Agency’s work to develop a much-needed guidance on natural history studies for rare disease drug development. The Draft Guidance serves as an important communication tool between the FDA and Sponsors on issues pertaining to natural history studies for rare disease drug development. Such guidance ensures that Sponsors have appropriate information for developing new therapies for rare disease patients, especially given that many rare diseases still do not have an FDA approved treatment. In the following pages of this letter, BIO has included general comments as well as line edits that we believe will make the Draft Guidance more useful for various stakeholders.

Biosimilars: BIO Comments on FDA Draft Guidance Nonproprietary Naming of Biological Products: Update

May 3 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Nonproprietary Naming of Biological Products: Update.

Digital Tech: BIO Comments on FDA Prescription Drug-Use-Related Software

Apr 29 2019
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the open docket on Prescription Drug-Use-Related Software.

E-labeling: BIO Comments on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act

Apr 15 2019

April 15, 2019

...

BIO Submits Comments on FDA Draft Guidance, Rare Diseases: Common Issues in Drug Development

Apr 11 2019
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the Draft Guidance on Rare Diseases: Common Issues in Drug Development.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 association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of diseases, and to prevent diseases in the first place. BIO commends the FDA for its efforts to update the 2015 Draft Guidance on Rare Diseases: Common Issues in Drug Development. The updated Draft Guidance serves as an important communication tool between the FDA and Sponsors on issues pertaining to rare disease drug development. Such guidance ensures that Sponsors have appropriate information for developing new therapies for rare disease patients, especially given that many rare diseases still do not have an FDA approved treatment. In the following pages of this letter, BIO has included general comments as well as line edits that we believe will make the Draft Guidance more useful for rare disease drug developers.

ICH: BIO Submits Comments on S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines

Apr 11 2019
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 acknowledges the limited value of dedicated studies in postweaning juvenile NHP is supported, as is the final paragraph in Section 4 which specifically addresses the situation of “pediatric first” clinical development in neonates.

REMS: BIO Submits Comments on REMS Assessment: Planning and Reporting

Apr 11 2019
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 Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance on REMS Assessment: Planning and Reporting.

BIO's 2019 Special 301 Submission

Mar 27 2019

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...

BIO Comments on Earnings Releases and Quarterly Reports

Mar 25 2019
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 reporting framework places an unhealthy emphasis on meeting or exceeding short-term forecasts, which engenders an inefficient outlook on short-term results. Due to the lengthy timeline for potentially life-saving drug discovery, which averages 10-15 years, biotech companies and their investors would be better served by a less frequent (e.g. semiannual) reporting regime that prioritizes long-term value creation. Biotech companies have unique business models and would benefit from scaled disclosure whereby smaller reporting companies (SRCs) and emerging growth companies (EGCs) report on a less frequent (e.g. semiannual) basis while preserving the flexibility to adopt more frequent (e.g. quarterly) reporting as they advance toward commercial stage.