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FDA Releases Agenda for New & Revised Guidances for Year 2018

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
Advertising 2 1
Biopharmaceutics 0 3
Biosimilarity 0 2
Clinical/Antimicrobial 4 1
Clinical/Medical 9 11
Clinical Pharmacology 8 8
Clinical/Statistical 3 3
Drug Development Tools 1 0
Drug Safety 2 3
Electronic Submissions 5 4
Generics 10 13
Labeling 7 6
Over-The-Counter 2 0
Pharmaceutical Quality/Microbiology 1 0
Pharmaceutical Quality/CMC 13 11
Pharmaceutical Quality/Manufacturing Standards (CGMP) 2 4
Pharmacology/Toxicology 1 1
Procedural 24 29
Rare Diseases 2 0
User Fees 2 2

 

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

 

 

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