Laws, Regulations, Guidance, and Concept Papers:
- A handful of guidance documents published this week from the FDA, EMA, and ICH.
- The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives.
Enforcement:
- 3 drug warning letters
- A handful of recalls
- 2 consent decree agreements
- A few import alerts
- Nothing this week in the enforcement area from Europe
- One form 483 addressed poor management of complaints, including those which resulted in death