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BIO Submits Comments on FDA's Action Plan for Collection, Analysis, and Availability of Subgroup Data

May 15 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products; Notice of Public Hearing; Request for Comments.” BIO shares the Agency’s commitment to better engage populations traditionally under-represented in clinical studies, while maintaining a focus on speeding safe and effective medicines to patients in need.

BIO and the Advanced Ethanol Council Send Letter to White House RE:Maintaining the Methodological Integrity of the RFS

May 15 2014
On May 15, 2014, the Biotechnology Industry Organization (BIO), the Advanced Ethanol Council, and associated signatories sent a letter to the White House expressing concern about the Administration’s impending decision around the Renewable Fuel Standard (RFS).

BIO Submits Comments on Considerations for Design of Early-Phase Clinical Trials for Cell and Gene Therapy Products

May 9 2014
BIO commends FDA on the release of this Draft Guidance, which will help to increase the efficiency of early clinical research for, and ultimately facilitate the development of, cellular and gene therapy (CGT) products. 

BIO and PhRMA Submit Joint Comments to FDA on Electronic Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act

May 9 2014
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.

Fuels America Sends Letter to President Barack Obama RE: the National Climate Assessment Report

May 8 2014
On May 8, 2014, Fuels America, which BIO is a member, sent a letter to the White House commenting on the most recent announcement of the National Climate Assessment report.  

Reprints: BIO Comments on Distributing Scientific and Medical Publications on Unapproved New Uses

May 1 2014
As with the FDA’s previous Guidance on this topic (2009 Guidance),1 BIO continues to support FDA‘s clarification of its views on the dissemination of medical journal articles and medical or scientific reference publications that contain truthful and non-misleading information, including new information about the uses of approved drugs, biologics and medical devices. In addition, BIO supports FDA’s inclusion in this Revised Draft Guidance of recommendations regarding manufacturer provision of medical journals and texts, as well as Clinical Practice Guidelines (CPGs), that similarly contain truthful and non-misleading information, including new information, about the uses of approved drugs, biologics, and medical devices.

U.S. Senate Committee on Appropriations FY15 Hearing: Driving Innovation through Federal Investments Testimony

Apr 29 2014
Chairperson Mikulski, Ranking Member Shelby, Members of the Committee, thank you for the opportunity to provide you with written testimony on the extremely important topic of driving innovation through federal investments.

BIO Comments on Draft Guidance for Industry on New Chemical Entity Determinations for Certain Fixed-Combination Drug Products

Apr 24 2014
BIO supports FDA’s proposed revised interpretation in the Draft Guidance of the term “drug” in the eligibility clause of the New Chemical Entity (NCE) exclusivity statutory provisions. ” FDA’s revised interpretation, as expressed in the Draft Guidance, is a permissible reinterpretation, and when implemented, will positively impact public health, by encouraging innovation in fixed dose combination drugs. In order to both benefit public health as well as to ensure fair and consistent treatment of fixed dose combination product exclusivity determinations going forward, BIO urges FDA to finalize and implement this new interpretation expeditiously.

BIO Submits Comments to FDA on Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs

Apr 22 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Request for Information (RFI) on “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.”

BIO Submits Comments to IOM Committee of Strategies for Responsible Sharing of Clinical Trial Data

Apr 13 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public trust in the clinical trial enterprise.