dicentra Regulatory Update 2013 Q1

Topics covered:

United States:

  • FDA’s proposed rules to amend cGMP for food facilities under FSMA

  • FDA’s Draft NDI Guidance Update

  • FTC’s Opinion and Final Order in the POM Wonderful Case

  • California’s Proposition 65

  • FDA Warning Letter Update


  • Repeal of UPLAR

  • NHPD Status of ApplicationQuarterly Report

  • Pathway for Licencing Natural Health Products Guidelines – Posting of Finalized Guidance Documents

  • New Prescription Drug List

  • New Monograph Revisions

  • New Quality Guidance Document

  • Improved Food Inspection Model

  • Low Risk Veterinary Health Product (LRVPP) pilot project

  • Canadian Anti-Spam Legislation

  • Temporary Marketing Authorization

  • Update on food-like NHP Transition