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Exhibit 985

Guidance for Industry on Consumer-Directed Broadcast Advertisements; Availability, 64 Fed. Reg. 43197 (Docket 97D-0302)

Exhibit 985 ยท Agency notice

Guidance for Industry on Consumer-Directed Broadcast Advertisements; Availability, 64 Fed. Reg. 43197 (Docket 97D-0302)

The agency sought public comment on a draft version of this guidance, which was announced in the Federal Register of August 12, 1997.

Notice announcing the final guidance. States the draft was announced in the Federal Register of 12 August 1997 and revised after comment.

Source
U.S. Food and Drug Administration
Date
9 August 1999
Quoted from
Summary, 64 Fed. Reg. 43197
Grade
Primary record
Document
https://www.govinfo.gov/content/pkg/FR-1999-08-09/html/99-20364.htm
Accessed
2026-11-10
Cited by
Findings citing this exhibit

Cited by

Finding INF-1.8
Primary record FDA issued final guidance on consumer-directed broadcast advertisements in August 1999, after announcing a draft on 12 August 1997. The Food and Drug Administration Amendments Act of 27 September 2007 required FDA to set standards for a clear, conspicuous and neutral major statement in television and radio drug advertisements within 30 months; FDA proposed a rule on 29 March 2010 and published the final rule on 21 November 2023, with compliance required from 20 November 2024.