Capture.JPGFarewell Commissioner Gottlieb

Sincere gratitude for your leadership and exemplary work during your current FDA tenure. You have been an inspiration.Capture.JPGEXIT INTERVIEW


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New steps to broaden patient participation in cancer clinical trials

FDA issued new recommendations for broadening cancer trial eligibility criteria

  • More representative of patient population
  • Maximize the generalizability of the trial results
  • Maximize understanding of therapy’s benefit-risk profile across the patient population likely to receive the drug in clinical practice

Broadening eligibility criteria to include:  Pediatric patients, Patients with HIV, Hepatitis B and Hepatitis C Virus infections, Patients with brain metastases, organ dysfunction and prior or concurrent malignancies

New Guidances

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Reorganization of CDRH

CDRH reorganization to implement efficiencies to integrate CDRH’s premarket and postmarket program functions

  • Reviewers, compliance officers and other experts would work in teams responsible for device oversight throughout the product’s development and commercialization
  • More integrated approach to device safety throughout the Total Product Life Cycle (TPLC) – already in pilot testing
  • Timeline: March 18, 2019 (begin) – September 30, 2019 (full implementation)

New Offices 

  • Office of Product Evaluation and Quality (OPEQ) :  Combines Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and  Office of In Vitro Diagnostics
  • Office of Policy – Two teams, the Guidance, Legislation and Special Projects Team and the Regulatory Documents and Special Projects Team
  • Office of Strategic Partnerships and Technological Innovation – Combines Science & Strategic Partnerships, Digital Health, Health Informatics and Innovation teams

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“Request to Connect” – A New Way for Patients to Connect with FDA

“Request to Connect” portal is live
  • Gives patients and caregivers a single entry point to the Agency for questions and meeting requests
  • Co-developed by Patient Affairs Staff and the medical product centers
  • Will route inquiries to appropriate medical product center or office for responses in effective and efficient manner
  • Opportunity for FDA to better understand patient perspective and advance science of patient input

Implanted Brain-Computer Interface (BCI) Devices for Patients with
Paralysis or Amputation – Non-clinical Testing and Clinical
Considerations

Implanted BCI devices increase ability to interact with environment and provide independence to patients with paralysis or amputation

  • Interface with nervous system to restore motor and/or sensory capabilities
  • Recommendations for non-clinical testing and study design considerations for IDE feasibility and pivotal clinical studies

Non-Clinical Bench Testing Considerations: Risk analysis, Electrodes, Leads and Connectors, Implanted casing and electronics, Output simulation measurements, Output simulation safety, Programmers/control unit, Radiofrequency transmitter and receiver, System level testing, factors for determining and design of animal studies

Clinical Study Considerations: Patient population, Home-Use, Duration and follow-up schedule, Inclusion/Exclusion criteria, Demographics, Treatment parameters, Endpoints including patient input (patient engagement. patient preference information, patient reported outcome measures)

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SAFE USE ALERTS: Surgical Staplers and Staples, Contact Lenses

Surgical Staplers and Staples:

  • Increased number of adverse events reported to the FDA since 2011: 366 deaths, > 9,000 serious injuries, > 32,000 malfunctions
  • FDA Actions:
    • Letter to Healthcare Providers
    • Issue draft guidance on recommendations to manufacturers
    • Hold public meeting of  General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee  to reclassify as Class II (from Class I)
    • Require premarket notification and establish mandatory special controls to help mitigate known risks 

Contact lenses 

  • Risk of several serious conditions including eye infections and corneal ulcers
  • Can develop very quickly, be serious and can cause blindness
  • Video on safe and effective use

Image credits: FDA

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