FDA BRIEF: Week of September 12, 2016

FDA Voice

 

Evaluating FDA’s Approach to Cancer Clinical Trials
By: Richard Pazdur, M.D., Acting Director, FDA Oncology Center of Excellence

Dr. Richard Pazdur

NEJM.JPG

FDA Oncology Center of Excellence (OCE) announced 2 months ago

 OCE and  Cancer Moonshot focus

  • leverage combined expertise in drugs, biologics, and device
  • most innovative approaches for new oncology prod

Commitment to optimally designed clinical trials

  • Emphasis on design for increased efficiency
  • Stakeholder engagement across government and industry to revisit eligibility criteria and enhance generalizability
  • Transition from Phase 1/2/3 paradign to a more seamless approach – expedire regulatory pathway
  • Use of ‘common control trials- with a common control arm and multiple different drugs with same indication and different companies
  • Use of ‘large simple trials’  with easily-measured endpoints safety or secondary efficacy endpoints
  • Public meetings to interact with patients and stakeholders.

NEJM Publication

READ


FDA and Access to Medications

By: Janet Woodcock, M.D., Director, CDER

Janet Woodcock

Recent news about the price spike of EpiPen has caused concern about medications become prohibitively expensive  and some people losing access to a potentially life-saving treatment.
FDA’s Role
  • doesn’t regulate drug prices – prices are set by the drug makers or distributors.
  • does approve new drugs, including generic versions of a drug, to improve competition in the marketplace.
  • Office of Generic Drugs prioritizes and expedites our review of applications for first generics
  • roadmap developed for expedited access

READ


FDA Facilitates Research on Earlier Stages of Alzheimer’s Disease

Alzheimer’s disease is a nightmare 

  • > 5 million diagnosed, 6th leading cause of death,  most common cause of dementia
  • limited treatment options

New Paths for New Alzheimer’s Drugs

2013 DRAFT GUIDANCE

  • focus clinical trials on stages before the onset of overt dementia
  • earlier and more precise identification of patients with early brain changes
  • earlier interventions, before further extensive brain damage, more successful

PUBLIC-PRIVATE PARTNERSHIP

READ


 

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