FDA Brief: Week of Mar 28, 2016

FDA Voice

califf

 

PRIORITIES- TEAMWORK TO ACHIEVE COMMON GOALS 

By: Robert M. Califf, M.D. Commissioner , FDA 

 

FDA FACTS

  • Regulates 20% nation’s economy
  • Mission to protect and promote public health
  • Makes decisions vital to the well-being of all Americans
  • High-quality and impartial judgments—although many may disappoint

CLEAR, REALISTIC, FOCUSED PRIORITIES

  • Workforce Initiative to build professional environment
  • Evidence Generation Systems to meet technological advances
  • Specific Critical Issues:

Pain: Opioid action plan

Tobacco product deeming: Oversight  over all tobacco products

Food Safety Modernization Act: Implementation

Antimicrobial resistance: Appropriate use and novel antimicrobials

Interagency effectiveness: With NIH, CDC, CMS

Precision Medicine: Future for biomedicine and agriculture

Cross-Cutting Issues: Combination products, improving product labeling

READ


 

perspective

leah.JPG

 

 

BIOSIMILAR PRODUCT LABELING 

Leah Christl, PhD,  Associate Director, Therapeutic Biologics, FDA CDER

 

PRESCRIPTION DRUG LABELING

  • Communicates the product’s safety and effectiveness information
  • Summarizes key scientific information on risk-benefit profile and appropriate use
  • Physician Labeling Rule (PLR) provides format and content

BIOSIMILAR PRODUCT

  • Similar to reference therapeutic biologic e.g. monoclonal antibodies, cell signaling proteins
  • Comparative data on structural/functional characterization, animal, clinical studies

BIOSIMILAR LABELING

  • Issued  GUIDANCE
  • Addition of “Biosimilarity Statement”
  • Incorporate relevant reference information; may differ from reference
  • Do not recommend  comparative data

READ


 

 

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