Presented by: Edward Basile

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FDA AUTHORITY OVER LABELING AND ADVERTISING (con’t) • Prescription drug is misbranded if all advertisements and other descriptive printed matter does not contain a true statement of information or brief summary relating to side effects, contraindications, and effectiveness as required <strong>by</strong> FDA regulations. (21 U.S.C. § 352(n)).
FDA AUTHORITY OVER LABELING AND ADVERTISING (con’t) • Restricted device (includes all Class III PMA devices) is misbranded if all advertisements and other descriptive printed matter do not contain a brief statement of the intended uses of the device and relevant warnings, precautions, side effects and contraindications. (21 U.S.C. § 352(r)).
Page 1 and 2: Presented by: Edward Basile
Page 3 and 4: THE FDC ACT’S DEFINITION OF LABEL
Page 5: 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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