Rules

Firm representatives should disclose their firm affiliation in public responses

Provide a copy of or mechanism to obtain current FDA-required labeling

State the publication date of referenced source publications

Match audio and text disclosures for audio-visual SIUU communications

Firm-generated presentation itself should include Q2 disclosures

Attribute safety/effectiveness conclusions to the source publication

Firm-generated presentation should identify firm-generated portions

Firm-generated presentation should follow safety claims with contributor disclosure

Disclose the FDA-approved use(s) and labeling limitations

Studies on normal subjects must disclose that fact unless drug is for normal individuals

Response should include complete reprints and literature, not just firm summaries

Ingredient info block must be unbroken when 502(n) data is shown

Ad ingredient order must match order on product label

Ingredient quantity in Rx drug ad must match product label

Trademark and controlled-substance symbols do not count as intervening matter

Established name should sit directly right of or below proprietary name

Established name must be at least half size when proprietary name is enlarged in running text

Established name outside running text must be at least half the proprietary name's size

Type size is measured by actual letter height, not point size

Established name required once in running text when proprietary name is not featured

Established name required once per detailed-information column

Bottom-of-screen supers do not require the established name

Audio portion of audiovisual/broadcast material need not include established name

Broadcast ads must include the major statement in audio (or audio/visual)

Reminder ads are not permitted for drugs with a boxed warning

Accompany unsolicited-request response with FDA-required labeling, if any

Public response should include a mechanism to access current FDA-required labeling, if any

Disclose that the unapproved use is unapproved and unestablished

Disclose labeling limitations, restrictions, cautions, warnings, or precautions about the unapproved use

Disclose contraindications from the FDA-required labeling

Disclose an applicable REMS and its goals

Public response should include specific medical/scientific contact information

Detailed off-label response should not be posted publicly in the same forum

Share reprints unaltered and unabridged

Reprinted article or its journal must be generally available through independent channels

Excerpted clinical reference resource sections must be unaltered and extracted directly

Shared CPG must rate the strength/quality of evidence for its recommendations

Shared CPG must be generally available through independent distribution channels

Shared reference text/digital resource must be generally available through independent channels

Firm-generated presentation must be provided together with the source publication

Submit Promotional Labeling Specimens at Initial Dissemination

Submit Prescription Drug Ad Specimens at Initial Publication

Submit Sample-Carrying Mailers Complete, Minus the Physical Sample

Attach Completed Form FDA-2253 to Ad/Labeling Submissions

Include Current Professional Labeling With Ad/Labeling Submissions

Submit promo materials for FDA review if disseminated within 120 days of approval

After 120 days post-approval, submit promo materials 30 days before use

Submit pre-approval-window promotional materials during preapproval review

Submit post-approval promotional materials at least 30 days before use

Submit advertisements and promotional labeling to FDA per 314.81(b)(3)(i)

Qualified personnel should review CFL promotional communications before dissemination

Continuing to share a retracted source publication is inconsistent with FDA's recommendation