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From Principle To Practice; An FDA Regulatory Submission Handbook. 1 Publish respected research guides. 2 Maintain high quality standards. 3 Provide excellent service. Biotech Pharma Solutions * Dr. Mark Brian Anderson * 18 Dover St, Suite 492 * Norwell MA * USA * 02061 Phone: (510) 219-5188. Contact Email; mbascience@hotmail.com. Consulting Website; www.biotechpharmasolutions.com. Book Sites: www.drugregulatoryhandbook.com. Sister Sites: www.dyersbeachhouse.com. Powered by Register.com.
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From Principle To Practice; An FDA Regulatory Submission Handbook. Chapter 1: From Principle to Practice. Chapter 2: The Food and Drug Administration (FDA). Chapter 3: Title 21 of the Code of Federal Regulations (21 CFR). Chapter 4: Selected Acts and Authorizations. Chapter 5: FDA Authority and Promotional Materials. Chapter 6: Selected FDA Forms. Chapter 7: Strategic Planning for FDA Meetings. Chapter 8: FDA Letters. Chapter 9: Investigational New Drug (IND) with your ‘Study Drug’. GxP Good x' Practice ...
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