Documents added in February-March 2017

Pharmaceuticals and Medical Device

  • EMA Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, Nov-16
  • FDA Guidance for Industry, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA Jan-17 DRAFT
  • FDA Preamble 21 CFR 4 Postmarketing Safety Reporting for Combination Products, Dec-16


  • EMA Questions and Answers on production of water for injections by non-distillation methods – reverese osmosis and biofilms and control strategies Jun-16 DRAFT
  • FDA Guidance for Industry, Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers Jan-17 DRAFT
  • FDA Guidance for Industry, Submission of Quality Metrics Data Nov-16 DRAFT
  • FDA Guidance for Industry, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Sep-16
  • FDA MAPP 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q), Jan-17
  • ICH Guideline, Development and Manufacture of Drug Substances, Q11, Questions and Answers, Oct-16

Medical Device

  • FDA Guidance for Industry, Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types, Jan-17
  • FDA Guidance for Industry, Medical Device Reporting for Manufacturers, Nov-16
  • FDA Guidance for Industry, Postmarket Management of Cybersecurity in Medical Devices, Dec-16
  • FDA Guidance for Industry, Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"), Dec-16
  • IMDRF Software as a Medical Device (SaMD): Application of Quality Management System, Mar-16 DRAFT