Description
"General Considerations for the Clinical Evaluation of Drugs" is an important companion piece and should be reviewed prior to reading these guidelines.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Antidepressant Drugs
Clinical evaluation of antidepressant drugs
Stakeholders
1Dockets Management Staff
Entity responsible for receiving written comments on the guidance.
Technical Details
Clinical Concepts
1Clinical Evaluation
The process of evaluating antidepressant drugs
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2