The following regulations apply to the IND application process:
21CFR Part 312 Investigational New Drug Application
21CFR Part 314 INDA and NDA Applications for FDA Approval to Market a New Drug (New Drug Approval)
21CFR Part 316 Orphan Drugs
21CFR Part 58 Good Lab Practice for Nonclinical Laboratory [Animal] Studies
21CFR Part 50 Protection of Human Subjects
21CFR Part 56 Institutional Review Boards
21CFR Part 201 Drug Labeling
21CFR Part 54 Financial Disclosure by Clinical Investigators
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- regulations apply to the IND application process
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- The Role of the CRC in a Clinical Trial
- Group Leader, Clinical Trial Management JOB VAcanc...
- CLINICAL RESEARCH ASSOCIATE (CRA):
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About Me
- ram
- Hyderabad, Andhra, India
- working as a clinical Research coordinator at yashoda Hospital,Somajiguda,Hyderabad
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