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Now Available! Revised APRIL 1, 2024 Books!      Also check out our NEW Book:  Good Clinical Practice Regulations in the US & the EU  (Book 1C)!

Book 8:  2024 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process

Book 8: 2024 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process

$ 17.95

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This spiral-bound, 5" x 7.5" book consists of primer on the drug development process, a review of the processes for obtaining FDA approval to market drugs, a summary of FDA activities and initiatives, as well as Clinical Research Resource's dictionary of clinical research terminology.  It's an ideal introduction for people new to the field of drug development and a handy reference for seasoned clinical research professionals. 

Who Uses this Book?
• Training departments, as training handouts
• Human Resources, as part of new-employee orientation
• Administrative support staff, as a convenient reference

What's the Price?
• 1-249 copies:  $17.95             • 250-499 copies:  $16.95
• 500-749 copies: $15.95          • 750+ copies:  $14.95

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

        Definitions and acronyms for over 1000 clinical research terms

      • Overview of New Drug Development and Submission
        Review Process
              • New Drug Development Process
              • IND Review Process
              • NDA Review Process
              • Generic Drug Review Process
              • OTC Drug Review Process
              • Presciption Drug Advertising and Labeling

      • Post Drug Approval Activities
              • Post-Marketing Surveillance
              • Medication Errors
              • Drug Shortages
              • Therapeutic Inequivalence Reporting
              • Patient Labeling and Risk Communication
              • Other Drug Initiatives
              • Orphan Drugs
              • Drug Registration & Listing System
              • Women's Health Initiatives
              • Pregnancy Category "C" Labeling
              • Pediatric Initiatives

Click here to see an enlarged pdf cover