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Combo Products: BIO Comments on FDA Draft Guidance, How to Prepare a Pre-Request for Designation (Pre-RFD)

Apr 14 2017
Re: Docket No. FDA–2017-D-0040: FDA Draft Guidance, How to Prepare a Pre-Request for Designation (Pre-RFD) ...

Combo Products: BIO Comments on Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council

Apr 14 2017
Re: Docket No. FDA–2017-N-0086: Suggestions, Recommendations and Comments for Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council ...

BIO Submits Comments Re: ICER Proposed Value Assessment Framework Revisions

Apr 11 2017
BIO submitted comments on the Institute for Clinical and Economic Review (ICER)'s call for proposed improvements to its Value Assessment Framework. While some of the proposed revisions have the potential to make progress toward aligning the Framework with the principles of individualized patient care and holistic value assessment, ICER must provide additional details with regard to how these proposed revisions will be operationalized before stakeholders can assess whether the revisions will meaningfully address critical gaps in the Framework.

Quality Metrics: BIO Comments on FDA Revised Draft Guidance "Submission of Quality Metrics Data"

Mar 30 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).

Re: FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods; Request for Comment

Mar 16 2017

March 9, 2017

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Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability

Mar 16 2017

March 13, 2017

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Endpoints: BIO Comments on FDA Multiple Endpoints in Clinical Trials

Mar 15 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Multiple Endpoints in Clinical Trials” (Draft Guidance).

Compounding: BIO Submits Comments to FDA on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

Mar 15 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s revised draft Guidance for Industry “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”

First-in-Human: BIO Submits Comments to EMA on Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Mar 15 2017
The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.” 

BIO President & CEO Greenwood Testifies to House Subcommittee on the Next Farm Bill

Mar 9 2017
The Biotechnology Innovation Organization (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 members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. Our members are working every day to solve the greatest challenges facing society – whether it is finding a cure for cancer, protecting the public against bio-terror threats, feeding hungry people nutritious food, or generating renewable fuels, renewable chemicals and biobased products. We support public policies, including government funding for key agencies and programs that unleash our members’ scientific innovation potential and grow the bioeconomy. BIO also is one of the founding members of the Agriculture Energy (Ag Energy) Coalition, a coalition of trade groups, companies, and organizations representing thousands of farmers and businesses across the United States who are developing an “all-of-the-above” approach to renewable energy, energy efficiency, and farm and forest resources.