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BIO Presents Statement at FDA PDUFA 6 Meeting

Jul 14 2015
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BIO Submits Comments on FDA on Biosimilars Q&A Draft Guidance

Jul 12 2015
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (May 2015)” (“Q&A Draft Guidance”).

BIO Submits Comments on Nonclinical Assessment of Investigation Enzyme Replacement Therapies

Jul 12 2015
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.”

BIO Letter of Support for 21st Century Cures Legislation

Jul 10 2015
We applaud Chairman Fred Upton (R-MI), Ranking Member Frank Pallone (D-NJ) and Congresswoman Diana DeGette’s (D-CO) efforts on H.R. 6., which takes important steps toward placing patients at the center of the drug development process, and we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on rare conditions and other unmet medical needs. We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.

DoD Medical Countermeasure Systems Industry Day

Jul 1 2015
On June 15, 2015, the Department of Defense's (DoD's) Joint Project Manager-Medical Countermeasure Systems (JPM-MCS) held a co-located Industry Day in conjunction with the BIO Convention in Philadelphia, Pennsylvania. The MCS Industry Day focused on industry feedback related to the DoD's proposed use of an Other Transaction Authority (OTA) contracting mechanism. 

BIO and PhRMA Submit Joint Comments to FDA on the Interim Assessment of the NME Review Program

Jun 23 2015
The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) submit these comments in response to the Federal Register notice entitled “Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket” issued by the U.S. Food and Drug Administration (FDA).

BIO Submits Comments on Draft PDUFA Meetings Guidance

Jun 8 2015
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.”

Letter to Senate Judiciary Committee on Managers Amendment to PATENT Act

Jun 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.

Letter to Senate Judiciary Committee on Managers Amendment to PATENT Act

Jun 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.

BIO'S Letter to House Appropriations Agriculture Committee re Section 9003 of the Agricultural Act of 2014

May 21 2015
On behalf of the biotechnology industry we are writing to encourage your support of full funding of Section 9003 of the Agricultural Act of 2014 (Public Law 113-79), the Biorefinery, Renewable Chemical, and Biobased Manufacturing Assistance Program, as you develop the Fiscal Year 2016 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act.