GMP topical


FDA: CDER Guidance Agenda for 2022

FDA: CDER Guidance Agenda for 2022

CDER released its Guidance Agenda for the year 2022. The list includes all guidances planned to be developed or finalised this year. The agenda should be seen as an indicator for the topics CDER is advancing to tackle but is not binding for the Center.

The document lists 98 new and revised guidances and is broken down into 17 separate categories. A new category Drug Development Tools makes its appearance. In total, 29 documents are new to the list while 66 documents are carryovers from last year.

The GMP-relevant category Pharmaceutical Quality CGMP still lists the two documents of last year:

  • PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
  • Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination


CDER:  Guidance Agenda for the calendar year 2022