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BIO Statement on President Trump’s Comments Supporting Biopharmaceutical Competition and Innovation

Washington, DC (January 31, 2017) – BIO issued the following statement regarding President Trump’s comments today supporting biopharmaceutical innovation:

BIO Statement on Prescription Drug User Fee Act Goals Letter

Washington, D.C. (July 15, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding the Prescription Drug User Fee Act (PDUFA) VI goals letter:

BIO Presents Statement at FDA PDUFA 6 Meeting

On behalf of the Biotechnology Industry Organization (BIO), thank you for the opportunity to provide our comments on the success of the PDUFA program and recommendations to enhance the program through the user fee reauthorization process.

BIO Submits Comments on Draft PDUFA Meetings Guidance

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the revised draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.”

BIO Launches Survey on FDA/Sponsor Interactions During Drug Development

Survey responses will help inform Prescription Drug User Fee Act VI negotiations

BIO Submits Comments on Proprietary Naming

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.

IT: BIO and PhRMA Comments on PDUFA V IT Plan

The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) are pleased to submit these comments in response to the Food and Drug Administration’s (FDA’s) Draft Prescription Drug User Fee Act V (PDUFA V) Information Technology Plan (IT Plan).

Pediatric Study Plans: BIO Comments on FDA Draft Guidance on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.” BIO commends FDA on the release of this Draft Guidance and shares the Agency’s commitment to ensure that safe and effective medicines are available for children.

Benefit-Risk: BIO Comments on FDA's Prescription Drug User Fee Act V Benefit-Risk Plan

BIO thanks the Food and Drug Administration for the opportunity to submit comments on the FDA Draft Plan on “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision Making.”

SMU: BIO Comments on Creating an Alternative Approval Pathway for Certain Drugs to Address Unmet Medical Need

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