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
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
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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