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
- Docket Number:
- FDA-1994-D-0267
- Issued by:
-
Guidance Issuing OfficeCenter 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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