FDA News: 30 years @ CDER, ZIKA Action, National Evaluation System – Drug and Device Digest

FDA BRIEF: Week of July 11, 2016




Director's Corner - 30 years at FDA

Breakthroughs in Drug R&D

  • Recombinant proteins
  • Monoclonal antibodies
  • Genetics and Molecular Medicine

Breakthroughs in Drug Regulation & Review

  • Accelerated approvals
  • Safety review
  • Rise of Clinical Pharmacology
  • Breakthrough Therapy program

Next Revolutionary Innovation

  • In CBER – gene therapy

Sustaining Innovation in Drug R&D

  • Basic Science – engine to drive a new understanding
  • Translational Science – biomarkers
  • Responsive Regulation – in keeping with the scientific advances

Long-Range Forecast – 30 yrs from now……

  • Splintering of diseases into molecular subtypes
  • Rise of precision medicine
  • Better diagnostics
  • Disease Prevention
  • Targeted Treatments


FDA Takes Action against Zika Virus

Robert Califf, M.D., Commissioner , Luciana Borio, M.D.,  Acting Chief Scientist

Robert Califf

Dr. Lu Borio

Alliance with World Health Organization and ANVISA (Brazilian Health Regulatory Agency) taking important steps to rapidly respond and minimize impact of  Zika virus outbreak.

Engagement with commercial and government developers, including the NIAID and BARDA on medical product development

  • Protecting Tissues and the Blood Supply
  • Supporting Diagnostic Development
  • Strategies to Suppress Mosquito Population
  • Facilitating Medical Product Development



Jeffrey Shuren, MD., JD. Director, CDRH

Robert Califf, MD, Commissioner

New technologies and methods to meet CDRH standards for

  • Reasonable assurance of Safety and Effectivenes (RASE)
  • Safe and Appropriate Use

National Evaluation System engaging all stakeholders to enable FDA to facilitate development and interpretation of more informative data essential for policy making and clinical decisions for individuals and populations.

Quickly detect and understand context of medical technology issues as they arise

Efficient system that rewards innovation that leads to better health outcomes, creating powerful incentives for continuous improvement and accelerating access to technologies that patients and physicians can use with the assurance of safety, efficacy, and a well-characterized balance of benefit and risk.


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