News about GMP/cGMP


CDER List for Planned Guidance Documents in 2018

The U.S. Food and Drug Administration (FDA) published the yearly list of new and revised draft guidances, CDER is planning to release in 2018. A total of 98 planned guidance documents have been set out which are categorised in 18 different themes.

Two documents are listed under the category „Pharmaceutical Quality/Manufacturing Standards (CGMP)“:

  • CGMP  Final  Interim  Guidance  for Human Drug Compounding  Outsourcing  Facilities Under Section  503B of the FD&C Act; Revised Draft
  • Field  Alert Report Submission

The category of “Pharmaceutical Quality/Microbiology” lists the

  • Microbiological  Considerations  for  Non-Sterile   Drug  Products

The related category „Pharmaceutical Quality/CMC” lists 13 additional guidances. If you are interested to take a look at these documents and the full list of guidances, please click here.


CDER: What's new related to drugs