When AZBio and AZBio Members work together with our partners across the country, we can make a difference. AZBio member Robert Shatz of Arizona CarbonTech Cooperative, Inc. shares a real-world example of advocacy and partnership in action.Continue reading
Category Archives: Advocacy and Regulations
FDA Publishes Prescription Drug User Fee Rates for Fiscal Year 2013
A Notice by the Food and Drug Administration on 08/01/2012 via The Federal RegisterContinue reading
Get the G2 on changes on the SBIR/STTR Program from the source
SBIR and STTR Policy Directives Are Finalized but Await Public Comment for ImprovementsContinue reading
Got Grants? Important Update: CCR is out SAM is In
The Central Contractor Registry (CCR) as well as the Online Representations and Certifications Application (ORCA) web sites and facilities have given way to the federal government’s new omnibus system, the System for Award Management (SAM).Continue reading
BioCentury This Week: A Difficult Balance at the FDA
Each Sunday, BioCentury This Week focuses on key issues in the bioindustry. On Sunday July 22, 2012, the focus of the program zeroed in on the recent news from Washington on the FDA Investigation regarding “whistle blowers” and the protection of industry confidential information.Continue reading
Washington Run Down – July 2012
As a member of the CSBA (Council of State Bioscience Associations), AZBio receives a monthy run down of the latest news from our nation’s capitol.
Here is the latest Washington Update from BIO and the C2Group. Continue reading
FDA Comment Request: Establishing a unique device identification system for medical devices
The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. Continue reading
Supreme Court Obamacare Ruling Fast Tracks Healthcare Issues
A Guest Post By Larry Aldrich, Executive Director, Arizona Business Coalition on HealthContinue reading
Comments Needed: SBA Releases Proposed SBIR & STTR Regulations
SBIR Inside Track: SBA Releases Proposed SBIR & STTR Regulations. Open for Public Comment Until July 16, 2012Continue reading
Performing Under PDUFA: The FDA Wants to Hear From You
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). Continue reading