Pharmaceuticals and Medical Device

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


Pharmaceuticals