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BIO comments to FDA Regarding the Regulation of Intentionally Altered Genomic DNA in Animals

Jun 20 2017
BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on the draft guidance for industry (GFI) #187, entitled Regulation of Intentionally Altered Genomic DNA in Animals2. This draft guidance would revise GFI #187 entitled “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs” (current GFI #187)3. 

BIO Comments to FDA on Genome Editing in New Plant Varieties Used for Foods

Jun 19 2017
BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on genome editing in plants.

BIO Comments to USDA on its 340 Biotech Rules

Jun 19 2017
BIO is pleased to submit these comments in response to the USDA Animal and Plant Health Inspection Service’s (APHIS’) request for public input on the proposed revisions to its biotechnology regulations in 7 CFR Part 340.

Patient Engagement: BIO Comments FDA Docket "Enhancing Patient Engagement Efforts Across FDA"

Jun 13 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on Enhancing Patient Engagement Efforts Across the Food and Drug Administration.

BIO IES: Advanced Biofuel RVP EPW Letter 170612

Jun 12 2017

BIO IES: Advanced Biofuel RVP EPW letter 170612

Jun 12 2017

Advanced Biofuel RVP EPW letter 170612

Jun 12 2017

GHG Benefits of the Consumer and Fuel Retailer Choice Act

Jun 7 2017

GHG Benefits of the Consumer and Fuel Retailer Choice Act

Jun 7 2017

BIO Submits Comments Re: 340 B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) Regulation Interim Final Rule

May 16 2017
BIO submitted comments in response to the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation Interim Final Rule (the "Interim Final Rule") published in the Federeal Register on March 20, 2017. In the balance of this letter, we discuss each of our concerns in detail, focusing on the need to delay the effective date of the Final Rule until HRSA can complete revisions to the Final Rule through notice-and-comment rulemaking that address: The significant burden of the “penny pricing” policy finalized in the Final Rule; The need to revise the regulatory definition of the “knowing and intentional” standard to comply with its statutory intent; and The need to revise the treatment of ceiling price calculations for newlylaunched drugs and the definition of “instances of overcharging” to mitigate the significant and undue burden these Final Rule provisions place on manufacturers.