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

Source:

CDER:  Guidance Agenda for the calendar year 2022