FDA News & Views: MyStudies App, Asthma and OTC Treatment, Improving Expanded Access, Modernizing Sterile Drug Inspections – Drug and Device Digest

Capture.JPGFDA MyStudies app

MyStudies app will aid researchers and industry in collecting real world patient level data

  • When linked to existing electronic health data
  • Will promote efficiencies in drug development and drug safety monitoring processes
  • Patients can securely enroll and participate in large scale pragmatic clinical trials or registries
  • Comply with FDA guidance and regulations regarding data authenticity, integrity, and confidentiality (21 CFR Part 11 compliant clinical trials)

Two versions of the app

  • Apple ResearchKit (iOS) framework
  • Open source ResearchStack framework, which runs on Google’s Android

App (iOS and Android), web configuration portal (WCP), and storage environment posted on GitHub to allow customization and use 




Asthma Management and OTC Treatment Option

About 8.3 percent of Americans — nearly 27 million people — have asthma

  • No cure for asthma and, in most cases, don’t know causes
  • Can reduce the number and severity of attacks
  • Develop an asthma action plan – with right medications

OTC Primatene Mist for temporary relief for symptoms of mild, intermittent asthma

  • Original OTC Primatene Mist taken off market in 2011- contained chlorofluorocarbon (CFC) propellants known to deplete the ozone layer
  • New version recently approved
  • Uses same active bronchodilator ingredient (epinephrine)
  • Redesigned device for use n people ages 12 years and older




New efforts to strengthen FDA’s expanded access program

Expanded Access (EA) program provides pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials

Steps taken for improvement

  •  streamlining the required supporting documentation
  • simplified the process for Institutional Review Board (IRB) review
  • guidance on use of safety data

Additional improvements based on independent assessment

  • mproving FDA’s public website content and investing in resources to support patient/physician program navigation
  • formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program,
  • Implementing Right to Try legislation



New Inspection Protocol Project (NIPP) to strengthen and modernize  inspections for sterile injectable drugs

New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a structured manner for more consistent oversight

  • Quickly assess state of quality in drug manufacturing facilities while maintaining flexibility to adapt inspections based on constraints e.g.  time or seriousness of violations
  • Easier to analyze data to find anomalies and inform decisions that can reduce risks to patients
  • Ensure more streamlined and consistent coverage and reporting of inspectional activities
  • Multiple pilots of NIPP protocols conducted
  • Integrate learnings into field activities – goal to have full implementation within two years


Image credit: FDA

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