IPEC Americas Guidelines / Documents

  1. 202106-02_Pharmeuropa_33.2_Nitrosamine Commenting_Final
  2. IPEC-Americas_USP_Response_IPA_intent_revise_FINAL
  3. IPEC-Americas_FDA-2020-D-2016_Policy_for_Testing_Alcohol_FINAL_4-16-2021
  4. IID GDUFA III - IPEC-Americas FINAL_share FDA
  5. ANSES Report -List of 37 Food Additives (English) (Word Version)
  6. E171 - Overview of EFSA Opinion (5-18-2021)
  7. Recommendations for Responding to Requests from USP for Samples Final
  8. IPEC-Americas_USP_Response GSP GC Prospectus Final
  9. IPEC-Americas_USP comments_Open_Forum_Feb 2021
  10. 2021_March FDA_Reports_Announcements
  11. IPEC-Americas_USP_Response_232_cutaneous_Final
  12. IPEC-Americas_USP_Response_oleyl_oleate_final
  13. 2021 CDE Tech Guide for CMC Changes of Innovative Drugs during Clinical Trials
  14. IPEC-PQG GMP Guide 2017_Final FR_format
  15. IPEC-Americas 2020 Year in Review
  16. USP Response to IA endorsement of IFAC comments
  17. USP response to IA Deferral of rev to Maltol monograph PF 46(2)
  18. IPEC-Americas_USP_Response_Glucose_Liquid_Final
  19. Pharmaceutical Lactose used in oral preparations is a low risk excipient
  20. Attachment A4 Drug Marketing Authorization Holder Change Dossier Requirements
  21. Attachment 3 Policy Interpretations of Provisions for Post-approval Changes of Medicinal Product
  22. Attachment 2 Implementation PAC
  23. Attachment A3 Provisions for Post-approval Changes of Medicinal Product
  24. IPEC-Americas endorsement of IFACs comments on GCs 2740_2800_2750
  25. 2021_Feb FDA_Reports_Announcements
  26. Editor Response to NaCMC letter to editor
  27. IPEC_2021 NaCMC letter to the editor FINAL LETTER 18 Jan 2021
  28. 2021-02-17 E171 - Advocacy Brochure-1

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