The Food and Drug Administration’s long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might not need to be tested in humans.Continue reading
Category Archives: Advocacy and Regulations
State Net Capitol Journal 02 13 2012
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the February 13, 2012 edition.
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State Net Capitol Journal for 02 06 2012
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the February 6, 2012 edition.Continue reading
AdvaMed explains the need for Medical Device Tax Repeal and Potential Job Impact
AdvaMed’s Stephen J. Ubl Shares Comments Regarding the Release of Proposed IRS Regs to Implement Medical Device Tax and Underscores Need for Swift RepealContinue reading
Ernst and Young Life Sciences Report for January 2012
Understanding the issues facing your company or industry is critical to anticipating and alleviating business risk. To assist you, Ernst and Young offers two Smoke Detector® Reports that can help you quickly identify new legislative, regulatory and legal news affecting your business. One report monitors the life sciences industry and the other focuses on corporate compliance.
State Net Capitol Journal for 01 23 2012
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the January 23, 2012 edition.Continue reading
State Net Capitol Journal for 01 16 2012
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the January 16, 2012 edition.Continue reading
FDA releases draft guidance on medical device applications
The Food and Drug Administration unveiled draft guidance Wednesday on how it reviews applications for low-risk medical devices under the 510(k) program and is requesting industry comment.
State Net Capitol Journal for 12 19 2011
AZBio partners with LexisNexis and State Net to bring you all the latest updates from Washington DC and around the nation. Check out the latest in the December 19, 2011 edition.Continue reading
SBIR and STTR Reauthorized for Six Years
Today the SBIR was reauthorized for a period of 6 years, ending September 30, 2017. This includes STTR, and what was the Commercialization Pilot Program (CPP), now to be known as the Commercialization Readiness Program (CRP). The reauthorization was included in the National Defense Authorization Act of 2012 (NDAA) HR.1540.
The bill has been sent to the President to sign the bill into law, and he has said he would.Continue reading