Survey covers FDA/sponsor interactions during drug development.
Share:
Press Release Summary:
BIO announced survey tool on FDA/Sponsor Interactions During Drug Development to better inform policy initiatives designed to improve FDA and drug sponsor coordination and communication during drug development. Survey will serve to inform next reauthorization of the Prescription Drug User Fee Act VI. By helping to identify areas where policies, regulations, and practices are working well and areas that need improvement, sponsor input will make process more efficient and effective.
Original Press Release:
BIO Launches Survey on FDA/Sponsor Interactions During Drug Development
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
WASHINGTON -- The Biotechnology Industry Organization (BIO) today announces a first-of-its-kind survey tool on FDA/Sponsor Interactions During Drug Development to better inform policy initiatives designed to improve FDA and drug sponsor coordination and communication during drug development. This will serve to inform the next reauthorization of the Prescription Drug User Fee Act (PDUFA VI), which will begin in late 2015 with final enactment expected in 2017.
“Sponsor input is critically important for BIO and the entire industry to understand the real challenges associated with the regulatory process to help guide our discussions with FDA and ultimately work with Congress to establish new and effective measures to implement under PDUFA VI”
“Sponsor input is critically important for BIO and the entire industry to understand the real challenges associated with the regulatory process to help guide our discussions with FDA and ultimately work with Congress to establish new and effective measures to implement under PDUFA VI,” said John Maraganore, PhD, CEO of Alnylam Pharmaceuticals and Chair of BIO’s Emerging Companies Section Governing Board.
Survey responses will help assess FDA-sponsor interactions during drug development and address problems, particularly those that result from inconsistencies between review divisions.
The survey will focus on individual clinical programs for products that are in the pre-clinical testing phase through the clinical testing phase, prior to submission of an initial NDA/BLA, and responses will be held strictly confidential, blinded, and aggregated.
Sponsor input will help identify areas where policies, regulations, and practices are working well and should not be changed; and identify areas where policies, regulations, and practices need improvement in order to make the process more efficient and effective.
Participants will have access to the survey tool 24 hours a day, seven days a week so that responses can be updated on a continual basis. The survey is open to all biopharmaceutical representatives regardless of membership within BIO. Participants will be provided with an annual report on the survey results and invited to join exclusive BIO webinars to discuss survey results with industry leaders and regulatory experts.
The survey can be accessed at https://fdasurvey.bio.org. Maraganore discussed the upcoming PDUFA VI reauthorization in a recent BIO Buzz Center video interview that can be accessed here.
About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter.” Subscribe to the BIO Newsletter.
Upcoming BIO Events
BIO Latin America Conference
September 9-11, 2014
Rio de Janeiro, Brazil
Livestock Biotech Summit
September 16-18, 2014
Sioux Falls, SD
BIO Investor Forum
October 7-8, 2014
San Francisco, CA
BIO Europe 2014
November 3-5, 2014
Frankfurt, Germany
BIO IPCC Conference
November 10-12, 2014
Nashville, TN
BIO Pacific Rim Summit on Industrial Biotechnology & Bioenergy
December 7-9, 2014
San Diego, CA
BIO International Convention
June 15-18, 2015
Philadelphia, PA
Contacts
Biotechnology Industry Organization (BIO)
Daniel Seaton, 202-470-5207
Web: www.bio.org
Blog: www.biotech-now.org
Twitter: @IAmBiotech
