Presented by: Edward Basile

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DEFINITION OF ADVERTISING • Advertisements regulated under Section 502(n) are defined <strong>by</strong> regulation to include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communications systems. 21 C.F.R. §202.1(1)(1).
FDA AUTHORITY OVER LABELING AND ADVERTISING (con’t) • Misbranding – A drug, device, or biologic is considered misbranded and subject to FDA enforcement action if its labeling is false or misleading in any particular. (21 U.S.C. § 352(a)). • Includes failure to reveal material facts (21 U.S.C. § 321 (n)). (321(n) refers to labeling or advertising.)
Page 1 and 2: Presented by: Edward Basile
Page 3: THE FDC ACT’S DEFINITION OF LABEL
Page 7 and 8: FDA AUTHORITY OVER LABELING AND ADV
Page 9 and 10: PRE-APPROVAL PROMOTION (con’t) Dr
Page 11 and 12: PRE-APPROVAL PROMOTION (con’t) De
Page 13 and 14: OTHER PRE-APPROVAL ACTIVITIES (con
Page 15 and 16: MANUFACTURER INVOLVEMENT IN CONTINU
Page 17 and 18: CONTINUING MEDICAL EDUCATION (con
Page 19 and 20: PRESS RELEASES • Product-specific
Page 21 and 22: INFORMATION ON THE INTERNET • Inf
Page 23 and 24: INFORMATION ON THE INTERNET (con’
Page 25 and 26: ENFORCEMENT OF PROMOTION AND ADVERT
Page 27: WARNING LETTERS FOR ILLEGAL PROMOTI

Presented by: Edward Basile

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