Related to PDA/FDA Pharmaceutical Supply Chain Workshop

• 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.
  
• FDA Evaluating Input from Industry on Nanotech Guidance
  Questions and comments covered FDA’s definitions of what constitutes a nanomaterial.
  
• 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.
  
• U.S. Lead in Nanotechnology Depends on Growth of FDA and Gov’t Initiatives
  European revenue from nanotech-enabled products is projected to surpass that of the U.S. by 2015, according to Lux Research.
  
• FDA Holds Public Discussion of User Fee Program for Biosimilars
  Initiative is one step in agency’s road to developing the final abbreviated approval pathway for biosimilars.
  
• What Will FDA Biosimilars Guidelines Mean for Industry?
  Agency hasn’t settled on requirements for interchangeability and exclusivity period for pioneer biologics.
  
• How Provenge Laid the Groundwork for Developing and Regulating Cancer Vaccines
  FDA’s recently issued guidelines pull from more than 20 years of research and clinical experience.
  
• Regulatory Environment Warms Up to Obesity Drugs and Could Heat Up Market
  With Vivus receiving a positive recommendation, analysts see CV risk as one that can be evaluated post-approval.
  
• Comments Sent to FDA on Its Draft Biosimilars Guidance Mostly Conveyed Discontent
  More rigorous testing to prove biosimilarity and safety were the biggest concerns.
  
• FDA’s Hearing for Biosimilars Showcased Issues Ranging From Definitions to Study Requirements to IP
  Industry appeared to provide broad support for draft rules but pointed to areas that need tweaking.
  
• Fewer Approvals and Filings Sully FDA Offensive
  Agency’s recent efforts to shake off industry criticism are not supported by the numbers.
  
• Obesity Drug Developers Post Steady Gains
  High clinical trial costs and slower FDA approvals are among the hurdles to obesity drug approval.
  
• Meningitis Outbreak Prompts Policy Review
  Compounding pharmacies anticipate new rules following the meningitis outbreak, including an answer to the longstanding question of federal vs. state oversight.
  
• Getting Cancer Immunotherapeutics Approved
  It’s not just the FDA standing in the way.
  
• FSD Drugs Advance as Women Push for Equal Access
  Drug development in this arena has proven difficult, but some successes have been reported recently.
  
• With GAIN, Less Pain
  Antibiotic drug developers welcome incentives, though cost, rules remain a challenge.
  
• 7 Biotech Trends for the Coming Year
  What does 2013 hold for the industry?
  
• Getting FDA to Yes
  As PDUFA, patent cliff drive 2012 approvals, can industry keep cranking out new molecules?
  
• Transgenic Salmon Prove Tough to Tackle
  Many salvos have been fired to prevent the introduction of genetically engineered fish into commercial aquaculture.