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T.J. Sharpe at the 2017 BIO International Convention

Mike Huckman interviews T.J. Sharpe at the 2017 BIO International Convention Buzz Center.

BIO Applauds House Passage of Food and Drug Administration Reauthorization Act (FDARA)

Urges swift Senate vote to ensure continuity of critical FDA functions   Washington, DC (July 12, 2017) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. House of Representatives:

BIO Congratulates Dr. Scott Gottlieb on Confirmation as FDA Commissioner

Washington, DC (May 9, 2017) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the confirmation of Dr. Scott Gottlieb as Commissioner of the Food and Drug Administration (FDA):

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the revised draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.”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(BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.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).