Close

PFDD: BIO Comments on FDA Draft Guidance Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019

...

PFDD: Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments

December 14, 2018

...

Benefit-Risk: BIO Comments on Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan

May 31, 2018

...

BIO Comments on FDA Draft Guidance Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products

March 27, 2018

...

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

Enactment of FDA User Fee package important victory for patients, medical innovation

BIO: Senate Passage of FDA User Fee Package Important Victory for Patients, Medical Innovation

Washington, DC (August 3, 2017) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. Senate today:

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: