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GUIDANCE DOCUMENT

E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions March 1995

Final
Docket Number:
FDA-1994-D-0267
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The objective of this guideline is to present an accepted set of principles for the safety evaluation of drugs intended for the long-term treatment (chronic or repeated intermittent use for longer than 6 months) of non-life-threatening diseases. 
 


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