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