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PART II EMERGING TRENDS: - INVESTIGATIONAL DRUG PROMOTION - PRESS/NEWS RELEASES AS PROMOTIONAL MATERIALS - COMPOSITE SCORE BENEFIT CLAIMS 14
Investigational Drug Promotion § 1 Warning Letter, 1 Untitled Letter in 2011 § October 18, 2012 Untitled Letter to Burzynski Research Institute, Inc. § November 27, 2012 Untitled Letter to Salix Pharmaceuticals, Inc. and Napo Pharmaceuticals, Inc. § April 25, 20<strong>13</strong> Untitled Letter to CBA Research, Inc. § Materials OPDP reviewed included: company websites, online press releases, web videos, booth brochures, and a podcast 15
Page 1 and 2: Trends in OPDP Enforcement Letters
Page 3 and 4: Trends & Emerging Trends 19 OPDP Le
Page 5 and 6: Presenting Risk Information: Legal
Page 7 and 8: Agency Guidance Activity § OPDP Di
Page 9 and 10: Examples (in Labeling) (cont.) § S
Page 11 and 12: Presenting Data: Legal Authorities
Page 13: § Doxil ® Website “In a retrosp
Page 17 and 18: Investigational Drug Promotion Exam
Page 19 and 20: Press/News Releases § Form 2253 id
Page 21 and 22: Examples of Press Releases in OPDP
Page 23 and 24: FDA’s DTC Advertising Composite S
Page 25 and 26: 25 TAKEAWAYS
Page 27 and 28: Closing Takeaways (cont.) § Don’

Slides (Updated 9/13/13)

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