Laws, Regulations, Guidance, and Concept Papers

A busy week on the guidance publication front for FDA, WHO, HPRA, and Health Canada. A busy weekend of reading material!

  • Among the most important from the FDA is the 21-page item on alternative mechanisms for complying with the GMPs for combination products.
  • The non-guidance area includes the usual collection from MHRA (including an inspectorate blog post), FDA, EMA, and HPRA.


  • Enforcement was light this week with only 1 FDA drug warning letter issued to an OTC firm in Taiwan.
  • Europe posted 1 notice of GDP non-compliance.
  • A handful of recalls and import alerts round out the area.
  • There was also a recent form 483 issued to Glenmark Pharmaceuticals Ltd (India), a site that manufactures solid oral dosage forms.