Go back

Qdossier Qsauri
"A"

adequate provision
Guideline or reference source
FDA www.fda.gov
Definition
An alternative way for drug companies to provide risk information about a drug in a broadcast ad. Drug companies generally must include all of a drug's risk information in a product claim ad. In print ads, they usually do this in the "brief summary." This brief summary would take many minutes to read or scroll down a TV screen. The law allows broadcast ads to include only the most important risk information if the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which has all the drug's risks. To meet the "adequate provision" requirement, the broadcast ad must provide ways to find the drug's FDA-approved prescribing information.   Broadcast ads can meet the "adequate provision" requirement by giving a number of sources for finding a drug's prescribing information. These include:   A healthcare provider (for example, a doctor) A toll-free telephone number The current issue of a magazine that contains a print ad A Web site address  

Send comments to info@qdossier.com Please read disclaimer before using Qsauri.