Close

BIO Comments on Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation

June 8, 2018

...

BIO Statement on Opioid Crisis Response Act of 2018

Washington, DC (April 24, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding S. 2680, the Opioid Crisis Response Act of 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BIO Comments on FDA Draft Guidance Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products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

...

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

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

...

BIO Comments on FDA Draft Guidance ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

...

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:

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):

Testimony of Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization

What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide FDA with a significant portion of the resources it needs to ensure that patients have timely access to safe and effective new drugs and biologics, generic drugs, biosimilars, and medical devices. This Committee also tilled the ground and successfully produced, with an overwhelming bipartisan House vote, the legislation that established an FDA pathway for the approval of biosimilars – the Biologics Price Competition and Innovation Act (BPCIA). BIO was an early and strong supporter of this legislation to create a facilitated and balanced pathway for greater competition in the biologics marketplace.