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: $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
• CFR Title 21: Food and Drugs (Revised as of April 1, 2023)
Parts 99 Dissemination of Information
200 General
201 Labeling
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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