FDA BRIEF: Week of June 26, 2017
eMDR System Enhancements and HL7 Individual Case Safety Reporting
Electronic Medical Device Reporting (eMDR) program’s system update
- Mandatory medical device reports from Manufacturers, Importers, Device User Facilities
- Updates available for public access, download, and review
- Specific changes being implemented outlined
Health Level 7 (HL7) Individual Case Safety Reporting (ICSR)
- Standard for capture of information needed to support submission of MDR reportable events
- Files have also been updated for review
Health Level 7 (HL7) Individual Case Safety Reporting (ICSR) Files
Generic Drug Development and Access Enhancements
- Drug Competition Action Plan to increase competition for prescription drugs and facilitate generic drug entry
- Publication of list of off-patent, off-exclusivity branded drugs without approved generics
- Revision to “Prioritization of Review of Original ANDAs, Amendments, and Supplements” for prioritized review of generic drug applications
- policy to expedite the review of generic drug applications where competition is limited
- FDA will unveil additional aspects plan
- Actions reflect administration’s broader work to improve access to prescription drugs
Safety of Compounded Drugs by Drug Quality and Security Act (DQSA)
Need for robust oversight over human drug compounding, dispensing prescription and strong coordination with state regulatory partners to protect public health
- Enactment of DQSA in 2013
- Oversight of compounding and implementing compounding provisions of the law
- > 400 inspections, including 109 inspections of outsourcing facilities
- > 150 warning letters issued
- > 50 letters referring inspectional findings to state regulatory agencies
- > 125 recalls involving compounded drugs
- 21 draft guidances, 10 final guidances, 3 proposed rules, a final rule, a draft memorandum of understandin
- Taking risk-based approach to maximize public health purpose
Antibiotic Misuse and Resistance
Dr. Woodcock discusses the issues surrounding the use and misuse of antibiotic medicines, as well as the emergence of antibiotic-resistant bacteria and how the issues are related.