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BIO Submits Comments on Male-Mediated Developmental Risk

Aug 8 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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.

BIO Comments on Established Conditions Reportable CMC Changes

Jul 30 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

BIO Comments on Established Conditions Reportable CMC Changes

Jul 30 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

BIO Submits Comments to U.S. Environmental Protection Agency’s Proposed Rule Titled “Renewable Fuel Standard Program: Standards for 2014, 2015, and 2016 and Biomass Based Diesel Volume for 2017

Jul 27 2015
The Biotechnology Industry Organization (“BIO”) is pleased to have the opportunity today to comment on the U.S. Environmental Protection Agency’s (“EPA’s”) recently published proposed rule titled “Renewable Fuel Standard Program: Standards for 2014, 2015, and 2016 and Biomass Based Diesel Volume for 2017.”    

Seventy Nine House Members Express Concern with H.R. 9, The Innovation Act

Jul 27 2015
A coalition of 79 house members have requested significant improvement upon language within H.R. 9, the Innovation Act, in order to preserve the effectiveness of Hatch-Waxman and the Biologics Price Competition and Innovation Act.

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BIO Submits Comments on FDA on Biosimilars Q&A Draft Guidance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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (May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