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Category Archives: Advocacy and Regulations
AdvaMed’s Steve Ubl Announces Move to PhRMA
Steve Ubl, president and CEO of AdvaMed will leave his post at AdvaMed in the fall to serve as president and CEO of PhRMA.
Ubl shared the letter below with the AdvaMed Board of Directors on Friday, September 25, 2015.Continue reading
21st Century Cures Progresses
21st Century Cures passes unanimously out of the House Energy and Commerce Committee.
“AZBio congratulates Members of the House Energy and Commerce Committee and all of the representatives of industry, patients, and our key federal agency partners on a truly collaborative effort to progress H.R. 6 – The 21st Century Cures Act.” Joan Koerber-Walker, President & CEO, Arizona Bioindustry Association (AZBio) and Chair, AdvaMed State Medical Technology Alliance Continue reading
AZBio Submits Comments On How SB1475 Will Increase Healthcare Costs
While AZBio and its members recognize that the State of Arizona and the legislature must work diligently to balance the State Budget – which includes implementation of SB1475 and a 5% rate cut to providers of healthcare services – the end result may ultimately increase the state’s healthcare spend rather than reduce it.Continue reading
Capital For Emerging Growth Companies: Six House Bills To Watch
The success of the Jumpstart Our Business Startups (JOBS) Act in the biotech industry means that the work of the Subcommittee on Capital Markets and Government Sponsored Enterprises has taken on increased importance for emerging biotech companies. Current bills being considered could help to further support the search for breakthrough treatments at the next generation of emerging growth biotech companies.Continue reading
Economic Impact of the Proposed $1B in Expanded University Research Infrastructure
Lasting economic impact, the kind that spans generations and creates jobs today and in the future depends on a series of strategic investments and commitments made by both the public sector and the private sectors.Continue reading
Building On Success For A Better Arizona: HB 2033, SB 1067
If we want to be globally competitive, we need to commit to the resources it takes to compete. As Arizonans, now is our opportunity to let our elected leaders know how important we believe this is for our state today and tomorrow.Continue reading
Bills to Repeal the Medical Device Tax Introduced in the House and Senate
Momentum for repeal of the Medical Device Excise Tax is building in the 114th Congress.Continue reading
Arizona Bioscience Votes
Whether you are mailing in Early Voting Ballots or planning to vote at the polls, it is important to exercise your right and privilege to vote.Continue reading
Add YOUR Voice to the FDA PDUFA VI Negotiations
In August, the Biotechnology Industry Organization (BIO) 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,” 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.
Dr. Maraganore discussed the upcoming PDUFA VI reauthorization in a recent BIO Buzz Center video interview that can be accessed here.