FDA News: eMDR Enhancements, Enhance Generic Drug Development, Compounded Drug Safety, Antibiotic Misuse/Resistance – Drug and Device Digest

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

eMDR System Enhancements

Health Level 7 (HL7) Individual Case Safety Reporting (ICSR) Files

Generics have the same quality as brand name drugsGeneric Drug Development and Access Enhancements


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.


Image credit: FDA



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