News about GMP/cGMP


CDER List for 2017 Guidance Documents Updated

This month the FDA has updated its yearly list of the new and revised draft guidances CDER is planning to publish in 2017.

Compared to the list published in January 2017 no changes were identified for the three categories


  • Biosimilarity
  • Pharmaceutical Quality/Manufacturing Standards (CGMP)
  • Pharmaceutical Quality/CMC.

Click here to take a look at the current list of guidances.



CDER Guidance Agenda