FDA Views: EvGen, Expedited Reviews, Continuous Manufacturing, FDA-China partnership – Drug and Device Digest

FDA BRIEF: Week of April 18, 2016

FDA Voice

 

What We Mean When We Talk About EvGen

Part I: Laying the Foundation for a National System for Evidence Generation

shermanRachel E. Sherman, M.D., M.P.H., Associate Deputy Commissioner for Medical Products and Tobacco

 

califfRobert M. Califf, M.D.,  Commissioner 

  • High-quality evidence derived from appropriately designed randomized controlled trials result in better outcomes for patients
  • However, most clinical practice guideline recommendations are not based on this standard
  • Therefore, FDA considering a national system for evidence generation (EvGen)
  • Foundational concepts—interoperability and connectivity
  • Interoperability : For use by patients, consumers, professional groups, payers, the medical products industry, and health systems by creating standardized approaches
  • Connectivity: Enable collaboration among patients, clinicians, hospital systems, health insurance organizations by leveraging all available data to provide answers to important public health questions.

 

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FDA’s Breakthrough Therapy Designation and Expedited Review Programs

moscicki

 

Richard Moscicki, M.D., Deputy Director for Science Operations, CDER, FDA 

BREAKTHROUGH THERAPY designation:

  • Drug candidates in early development that have the potential to be breakthroughs
  • Intended to treat a serious condition and has preliminary clinical evidence
  • Receive enhanced communication and input from CDER
  • By March 2016: 342 requests; 111 granted

ACCELERATED APPROVAL designation

  • Drug candidate for serious condition and advantageous over available therapies
  • Use of surrogate endpoint- change indicators likely to predict clinical benefit
  • Require post-approval to confirm clinical clinical benefit

FAST TRACK designation

  • Drug candidates for serious condition
  • Non-clinical demonstration of potential to address an unmet medical need.
  • Obtained very early in drug development

All can lead to:

PRIORITY REVIEW designation

  • For very serious condition, trials have been completed, significant improvement in safety, effectiveness or both
  • Reduced FDA review time – but review standards not compromised

Areas of overlap:

Breakthrough Therapy drug would also receive a Priority Review and could receive an Accelerated Approval as part of its path to patients

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Continuous Manufacturing Has a Strong Impact on Drug Quality

yu.JPG

 

By: Lawrence Yu, Ph.D. Deputy Director, Office of Pharmaceutical Quality, CDER

 

 

  • Little change in pharmaceutical production over the last 50 years
  • Traditional  “batch” technology — many stops and starts in a series of steps
  • New technology — continuous manufacturing — faster production, reliable products
  • Decreases manufacturing costs with possible lower drug prices

Some manufacturers building continuous manufacturing into their processes

  • VERTEX: Orkambi (lumacaftor/ivacaftor) – cystic fibrosis drug
  • JANSSEN: Prezista (darunavir)- HIV-1 infection

Draft Guidance by Emerging Technology Team – ETT

ETT.JPG Reviewed in this blog

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Strengthening Partnerships: FDA’s China Office Engages in Key Outreach with Chinese Provincial FDA, Academia, and Industry

chinaBy: Leigh Verbois, Ph.D., Director of FDA’s China Office in the Office of International Programs

独木不成林,单弦不成音  ‘A single tree makes no forest, one string makes no music.’

 

  • China – home to a significant number of FDA-regulated medical product manufacturers
  • Mission to collaborate with Chinese regulators, industry and academia to ensure medical products manufactured for the U.S. market are safe and effective
  • FDA China office met with key leaders and experts across the Yangtze river delta

SHANGHAI: Students and faculty at East China University of Science and Technology’s School of Pharmacy and China Pharmaceutical University, .U.S. Embassy Consul General on  FDA priorities in the region.

NANJING: Jiangsu FDA, regional regulator, to share information on  U.S. safety standards

SUZHOU: Town hall meeting with  China’s Association for Medical Device Industry

HANGZHOU: Provincial FDA officials on collaboration on future medical device and drugs

ZHEJIANG: Industry roundtable on pharmaceuticals and Zhejiang FDA

 

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