For year 2018, Centre for Drug Evaluation and Research (CDER) of USFDA is Planning to Published New & Revised Draft Guidances. FDA has released its Agenda for publishing the guidance on January 19 2018.
In FDA’s Agenda, there are total list of around 98 New & Revised Draft Guidances from 18 different categories including
Compare to year 2017 this year four new categories are added which are Drug Development Tools, Over-The-Counter, Pharmaceutical Quality/Microbiology, and Rare Diseases. However there is no guidance in this year’s Agenda from Bio- pharmaceutics and Bio-similarity categories compare to year 2017.
Here is the summary of New & Revised Draft Guidances Agenda for 2018 and 2017.
|CATEGORY||As per Year 2018 Agenda||As per Year 2017 Agenda|
|Drug Development Tools||1||0|
|Pharmaceutical Quality/Manufacturing Standards (CGMP)||2||4|
For year 2018 Maximum guidance’s FDA is planning to publish are from Procedural category (24) however in the last year Agenda i.e. year 2017 number was 29 from this category:
2018 Guidence Agenda