The Most-Trusted Regulations & Guideline References on the Market.
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The Most-Trusted Regulations & Guideline References on the Market.
Celebrating 19 Years of Excellence.
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Free 1-day Trial: Selected Regulations & Guidance for Drug Studies
• CFR Title 21: Food and Drugs (As of yesterday's date)
Parts
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
• ICH Guidelines (US, Step 5)
E6(R2) Good Clinical Practice (Includes R2 Addendum)
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• Additional FDA Guidance Documents:
FREE
Book e1: Selected Regulations & Guidance for Drug Studies
• CFR Title 21: Food and Drugs (As of yesterday's date)
Parts
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
• ICH Guidelines (US, Step 5)
E6(R2) Good Clinical Practice (Includes R2 Addendum)
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• Additional FDA Guidance Documents:
$17.95
Book e2: Selected Regulations & Guidance for Device Studies
$17.95
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