Related to U.S. Lead in Nanotechnology Depends on Growth of FDA and Gov’t Initiatives

• DNA to Hang Your Hat On
  Scientists are coming up with amazing new uses for DNA origami.
  
• On the Menu: Supersized Soda Wars
  The NYC ruling halting the ban on large-sized sugary beverages is unlikely to stop future court fights over anti-obesity laws.
  
• GMO Rider: ‘Monsanto Protection’ or ‘Farmer Sustainability’?
  As Washington embraces GMOs, opponents look to studies, states, and retailers for support.
  
• GEN Congressional Hall of Fame
  Biomedical research has friends in high places. Meet them.
  
• GEN Hall of Shame
  Meet the Congressional enemies of research funding.
  
• Osiris’ Race to Market an FDA-Approved Stem Cell Product
  Mesenchymal stem cell therapy Prochymal is in Phase III but still has challenges to overcome.
  
• Changes Brewing at the FDA for Orphan Drugs
  Initiatives to de-risk drug development could include redesigning clinical trial requirements.
  
• 2011 Budget Outlook: Trim, Cut, Then Slash
  Agencies like the FDA and NIH are looking at potentially huge cuts.
  
• FDA Panel Hearing Suggests Medical Professionals May Play Role in Direct-to-Consumer Testing
  Changes including more regulation may take some time, as recommendations for the agency are yet to be finalized.
  
• NIH and FDA Taking Partnership for Regulatory and Translational Science One Step at a Time
  Over the past year, initiative named members, held two meetings, and gave out $9.4 million.
  
• FDA Outlines Strategic Priorities but Action Is Further Out
  The agency will take at least another year to flesh out plans.
  
• Genentech Prepares to Vouch for Avastin’s Use in Breast Cancer in FDA Hearing
  Company will present details on a so-called confirmatory study and biomarker data.
  
• Diagnostic Market Stakeholders Take Aim at FDA’s RUO/IUO Draft Guidance
  Among potential changes is that manufacturers will have to anticipate customers’ intended use of their IVD products.
  
• Concurrent Dx/Rx Review Will Require More Collaboration at FDA and More Outreach by Industry
  Agency issued draft guidance on companion diagnostic approval on July 14.
  
• As Comment Period Ends, FDA Seeks to Clarify Conflict of Interest Rules
  Agency’s draft guidance should be coupled with HHS’ proposals from last year, which are still being reviewed.
  
• Efforts to Standardize Molecular Imaging Blossoms as Industry and Agencies Unite
  Firms are more interested in leveraging the value of this method in clinical development.
  
• Extent of Feedback on RUO/IUO In Vitro Dx Draft Guidance Means Changes Not Expected Soon
  Industry voiced several complaints during agency’s comment period and provided some evidence of negative consequences.
  
• FDA Details Requirements for Regulatory Submissions of Genomic Biomarkers
  Agency hopes efforts to streamline biomarker development will advance more into the clinic.
  
• FDA Aims to Bridge Communication Gap with Drug Industry During Reviews Through PDUFA V
  Heavier time investment early on is expected to translate into a faster, more streamlined approval process.
  
• Avastin Label Changes Reignites Debate: Is OS or PFS the Better Regulatory Endpoint?
  A recent panel discussion set the stage for defining standards for drug approval as separate from those for treatment decisions.