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  5. External Peer Review of FDA’s Systematic Review of Safety Literature Regarding N-Acetyl-L-cysteine (NAC)
  1. Peer Review of Scientific Information and Assessments

External Peer Review of FDA’s Systematic Review of Safety Literature Regarding N-Acetyl-L-cysteine (NAC)

Title of the Review:     
External Peer Review of FDA’s Systematic Review of Literature Regarding N-Acetyl-L-cysteine (NAC)

Tentative Assessment:    
Influential Scientific Assessment

Agency Contact:         
Leslie Steen, PhD, DABT

Office or Center:         
CFSAN/ODSP

Subject of the Review:    
A systematic review of the literature related to NAC and its adverse health effects on humans.

Purpose of the Review:    
To conduct an expert peer review on the protocol, results analysis, and conclusion of the systematic review of NAC.   

Type of Review:
Individual letter reviews

Timing of Review:        
Fall/Winter 2023

Number of Reviewers:
3-5

Primary Disciplines/Types of Expertise of Reviewers:
Expertise in toxicology and risk assessment

Reviewers Selected by:    
Designated Outside Organization

Opportunities for the Public to Comment:     
No

If yes, briefly state how and when will these opportunities be provided:    
N/A.

Peer Reviewers Provided with Public Comments:     
No

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