FDA Views: Pre-RFD for Combination Products, Naloxone Access, Cardiovascular Medicine future, Zika Safety, BIA 10-2474

FDA BRIEF: Week of August 8, 2016


Making Continuous Improvements in the Combination Products Program: The Pre-Response For Designation (RFD) Process

Thinh Nguyen, Director, Office of Combination Products

Rachel E. Sherman, M.D., M.P.H., FDA’s Associate Deputy Commissioner 

Thinh Nguyen

Rachel Sherman

Agency making changes to internal procedures for responding to RFD communications from Office of Combination Products (OCP)

  • Pre-RFD process: Similar to RFD process;  OCP’s goal for Pre-RFDs  to respond to sponsors within 60 days following
  • Can be used at any point during medical product development
  • FDA preliminary feedback based on structured and efficient process


FDA Supports Greater Access to Naloxone to Help Reduce Opioid Overdose Deaths

By: Karen Mahoney, M.D., Deputy Director, Division of Nonprescription Drug Product

Overdose deaths involving prescription opioids tripled since 1999 –28,000 deaths in 2014

Tragedies avoided with immediate administration of  naloxone (injection, nasal spray) to stop or reverse overdose effects

FDA is exploring options to make naloxone more available: FDA’s opioid action plan 

  • Pursue approval of OTC naloxone product
  • Label with consumer-friendly instructions
  • Label comprehension testing


The Future of Cardiovascular Medicine From the Regulatory Perspective 

By: Robert M. Califf, MD

The field of cardiovascular medicine has been an exemplary partner with the FDA

Entering  new era in medicine characterized by dramatic accelerations in biological and information sciences and near-ubiquitous uptake of social media and personal devices

Need for integration of complex measurement and decision support with traditional devices, drugs, and biologics. Must involve entire ecosystem of which the FDA is a part. Efforts in:

  • Evidence Generation
  • Phenotyping
  • Integrative Biomarkers And Monitoring
  • Targeted Therapy
  • Devices
  • Regenerative Medicine
  • Nutrition And Diet
  • Lifecycle
  • Disparities

FDA Working to Keep the U.S. Blood Supply Safe from Zika and other Emerging Threats

 By: Peter Marks, M.D., Ph.D., Director, CBER

Luciana Borio, M.D., Acting Chief Scientist


  • Top priority to help assure that the blood supply is safe
  • Close collaboration with other government agencies, e.g. Centers for Disease Control and Prevention (CDC), and non-governmental partners, e.g. blood collection establishments and screening test developers.
  • Recommendations to reduce the risk of its transmission through blood
  • Working with manufacturers to speed development of Zika screening tests
  • Working with the Biomedical Advanced Research and Development Agency (BARDA) to facilitate evaluation of tests and other measures




First phase 1 clinical trial of BIA 10-2474, fatty acid amide hydrolase (FAAH) inhibitor

  • In France in Jan 2016
  • One death
  • Five hospitalization – Four with neurological injury

FDA received information from European Medicines Agency (EMA) and French national medicines agency (ANSM)

  • Comprehensive review of safety information
  • BIA 10-2474 exhibits a unique toxicity that does not extend to other FAAH drugs
  • No BIA 10-2474 trials in US;  will establish the appropriate path forward for FAAH inhibitors under investigation in the U.S.


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