Related to Will FDA Bid Adieu to Auld Lang Syne and Open Up to New Drugs and Devices?

• Policy Makers, Regulators Are Trying to Fortify Focus on Treating Superbugs
  Legislation and FDA rules have been slow to come, but all voice a sense of urgency.
  
• Latest Guideline Summary Document Solidifies EMA as Front Runner in Biosimilar Regulation
  Agency sought to answer various procedural questions that could come up during presubmission meetings.
  
• European Commission’s Definition Roils Industries with Eye on Nanomaterials
  Some argue that guidance is too narrow and will force companies into costly compliance procedures.
  
• Reports Acknowledge FDA Progress but Cite Concerns on Agency Priorities, Management
  A major area of concern is the lower number of drugs that get the go-ahead after first review.
  
• FDA Reform Legislation Emerges as Exception to Washington Gridlock
  Bill includes reauthorization of PDUFA, which adds fees for generic and biosimilar developers.
  
• Cliff Spells Danger for Biotechs
  If Obama and Congress cannot agree, key agencies face cuts while tax changes would dampen new investment.
  
• Building a Self-Destructive Mosquito
  Genetically modified mosquitos could be a way to curb the spread of dengue fever in Florida.
  
• Biosimilars: Not So Far So Fast
  Regulatory issues are among the hurdles that are slowing down biosimilar production.
  
• 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.
  
• 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.
  
• FDA Tries to Address Some Concerns Over Nanotech in Biotech
  More details are needed, but developers now have a better idea of what constitutes nanomaterials.
  
• 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.