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Book 7:  Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling

Book 7: Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling

$ 15.95

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This spiral-bound, 5" x 7.5" book is a compilation of the FDA regulations and guidance documents that govern the marketing, advertising and labeling of drugs. It includes such topics as:

• Adverse reactions section of labeling
• Consumer-directed broadcast advertisements
• Marketing of prescription drugs
• Clinical studies section of labeling

Who Uses this Book?
• Pharmaceutical marketing and advertising staff
• Clinical research staff, as a cross-training tool
• Advertising agencies working for pharmaceutical organizations
• Medical writing staff
• Legal/Regulatory/QA staff

What's the Price?
• 1-249 copies:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

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, 2015)        Parts    99    Dissemination of Information
                 200    General
                 201    Labeling (Revised 2015)
                 202    Prescription Drug Advertising
                 203    Prescription Drug Marketing
                206    Imprinting of Drug Products
                 208    Medication Guides
                 299    Drugs: Official/Established Names
              312.7    Promotion/Charging for Investigational Drugs
            314.81    Other Postmarketing Reports
          314.550    Promotional Materials
          314.560    Termination of Requirements
                        

• FDA Guidance for Industry
        • Industry-Supported Scientific and Educational Activities
        • Consumer-Directed Broadcast Advertisements
        • Qs & As on Consumer Broadcast Advertisements
        • Clinical Studies Section of Product Labeling
        • Adverse Reactions Section of Product Labeling
        • Dosage and Administration Section of Labeling for Human
          Prescription Drug and Biological Products — Content and Format
        • Product Name Placement, Size, and Prominence in Advertising
           and Promotional Labeling
        •
Labeling for Human Prescription Drug and Biological Products
           – Implementing the PLR Content and Format Requirements

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