Laws, Regulations, Guidance, and Concept Papers

  • FDA published 6 draft guidance addressing a variety of gene therapy issues. These cover a range of topics and have been promised by FDA.
  • Another 2 guidance were also published this week.
  • No guidance was published by the EMA.
  • WHO published 1 document.
  • The non-guidance collection included the usual sets from MHRA, EMA, FDA, and associated bodies.
  • Among the more interesting is the MHRA publication of issues commonly identified in clinical trial applications, and part II in one of the inspectorate blog entries.

Enforcement:

  • FDA published only 1 warning letter this week to an API firm in China.
  • OPDP published their 3rd untitled letter this year.
  • To be noted are 2 483s to compounding firms and 2 483s to pharma firms including a Hospira site in India (another 32-page 483).
  • A variety of recalls and 2 safety alerts.