Presented by: Edward Basile

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PRE-APPROVAL PROMOTION (con’t) Methods of Promotion • Scientific journal articles distributed <strong>by</strong> a manufacturer’s representatives are labeling and can misbrand a product • A manufacturer can be responsible for unapproved claims made <strong>by</strong> a physician or other third party, if: – there is a financial relationship between the physician and the manufacturer, or – the statements are made at the request of the manufacturer
OTHER PRE-APPROVAL ACTIVITIES (con’t) Recruiting Clinical Investigators • For unapproved PMA devices, drugs or biologics, FDA permits manufacturers to distribute “Notices of Availability of an Investigational Drug/Device/ Biologic” to recruit investigators for clinical studies. • Notices must be limited to sponsor’s name/address; how to apply as an investigator; how to obtain investigational product; a list of investigator responsibilities; objective statements about product; and description of protocol.
Page 1 and 2: Presented by: Edward Basile
Page 3 and 4: THE FDC ACT’S DEFINITION OF LABEL
Page 5 and 6: FDA AUTHORITY OVER LABELING AND ADV
Page 7 and 8: FDA AUTHORITY OVER LABELING AND ADV
Page 9 and 10: PRE-APPROVAL PROMOTION (con’t) Dr
Page 11: PRE-APPROVAL PROMOTION (con’t) De
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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