This spiral-bound, 5" x 7.5" book is a compilation of FDA regulations and guidance documents that govern the conduct of clinical trials for drug research and submission of applications to FDA for marketing approval (NDAs). It includes all of 21 CFR Part 314 on NDAs.
Who Uses this Book and How?
• Clinical Research staff, as job aids
• Training departments, as training handouts
• Human Resources, as part of new-employee orientation
• Legal/Regulatory/QA staff, for company-wide distribution
What's the Price?
• 1-99 copies: $22.95 • 100-249 copies: $21.95
• 250-499 copies: $20.95 • 500+ copies: $19.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title
• CFR Title 21: Food and Drugs (Revised as of April 1, 2024)
11 Electronic Records/Electronic Signatures
50 Protection of Human Subjects
54 Financial Disclosure
56 Institutional Review Boards
312 Investigational New Drug Application
314 Applications for FDA Approval to Market a New Drug
• Index to 21 CFR Parts 11, 50, 54, 56, 312, 314
• ICH Guidelines (US, Step 5)
E6(R2) Good Clinical Practice (Includes R2 Addendum)
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E8(R1) General Considerations for Clinical Trials
• Selected FDA Information Sheets, Guidance for IRBs, Clinical Investigators and Sponsors
- FAQs on IRBs and informed consent
- Cooperative Research
- Non-Local IRB Review
- Sponsor-Investigator Relationship
- Charging for Investigational Products
- Recruiting Study Subjects
- Payment and Reimbursement to Research Subjects
- Screening Tests Prior to Enrollment
- Off-Label Use of Marketed Products
- Emergency Use of Investigational Products
- Treatment Use of Investigational Drugs
- Waiver of IRB Requirements
- Drug Study Designs
- Evaluation of Gender Differences
- FAQs on Form FDA 1572
- FDA IRB Inspections and Clinical Investigators
- Clinical Investigator Disqualification
• PhRMA Principles on the Conduct of Clinical Trials
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