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Orphan Drugs: BIO Comments on FDA Draft Guidance Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

Feb 16 2018

Re: Docket No. FDA-2017-D-6380: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

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PFDD: BIO Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

Feb 16 2018

Re: Docket No. FDA–2017-N-5896: Public Workshop: Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

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BIO Comments on FDA Draft Guidance Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

Feb 16 2018

Re: Docket ID: FDA-2017-D-6617: Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

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RMAT: BIO Submits Comments on FDA Draft Guidance Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Feb 16 2018

Re: Docket No. FDA-2017-D-6159: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

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Biofuel Advocates' Letter to EPA Administrator Pruitt on 2019 Cellulosic Volumes

Feb 15 2018
As the U.S. EPA begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), a group of trade association advocates encourage the agency to take a renewed look at commercially ready cellulosic biofuels.

BIO Food and Agriculture Section Comments to FDA on Guidance on Consultation Procedures: Foods Derived from New Plant Varieties

Feb 9 2018
February 9, 2017 The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register1 regarding information collection burdens associated with its “Guidance on Consultation Procedures: Foods Derived from New Plant Varieties.”

BIO Food and Agriculture Section Comments to FDA on Review of Existing General Regulatory and Information Collection Requirements

Feb 8 2018
February 5, 2017 The Food and Agriculture Section of the Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register entitled “Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration,” as well as several related Center-specific notices.

Pediatrics Rare Disease: BIO Comment Letter on FDA Draft Guidance Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model

Feb 8 2018

Re: Docket No. FDA-2017-N-6476: Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability...

BIO Comments on FDA Draft Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

Feb 2 2018
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DSCSA: Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Jan 26 2018

Re: Docket No. FDA–2017–D–6526: Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Draft Guidance For Industry

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