Letters, Testimony & Comments

The Biotechnology Innovation Organization’s (“BIO”) Industrial and Environmental Section (“IES”) is pleased to provide the U.S. Environmental Protection Agency (“EPA”) input to inform its Task Force evaluation of existing regulations under Executive…

BIO is supportive of EPA’s proposal. In BIO’s view, granting the petitions in question would add unnecessary regulatory complexity and uncertainty to the Renewable Fuel Standard ("RFS") program, jeopardize U.S. economic and job growth, and would…

BIO submitted comments to the Food and Drug Administration (FDA) on topics that may be considered by the Food and Drug Administration Combination Product Policy Council. BIO is generally supportive of the criteria listed to determine what topics…

BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, How to Prepare a Pre-Request for Designation (Pre-RFD). BIO supports continued improvements to the review process of combination products. BIO says the draft…

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…

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(BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).

March 9, 2017Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852.Re: FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods; Request for CommentTo whom it may concern…

March 13, 2017Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20852Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of…

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(BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s revised draft Guidance for Industry “Mixing, Diluting, or Repackaging Biological Products Outside the Scope…

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Multiple Endpoints in Clinical Trials” (Draft Guidance).