Laws, Regulations, Guidance, and Concept Papers

  • Among guidance documents this week are 5 from FDA
  • 4 from EMA
  • 1 each from Health Canada, HPRA, and IMDRF
  • 2 from EMA/EC address gene therapy
  • Non-guidance documents include the usual collection from MHRA, FDA, and EMA.
    • Included here are expansion and renewal of the EU and Japan Mutual Recognition Agreement and a Biosimilar action plan from FDA.

Enforcement:

  • 2 drug GMP warning letters.
  • FDA also made available a 24-page form 483 issued to the Akorn Inc. site in Decatur, IL.
    • The primary focus of the observations is aseptic manufacturing of sterile products.
    • Several of the observations are noted to be repeats from previous inspections, never a good thing.
  • We have a few recalls this week including 24 kratom products with microbial contamination.
  • A few new import alerts were announced among the ones we follow.