Label for the Drug

The FDA approval process is about creating and obtaining a label for the marketing of the drug. The approval of the label by the FDA is the final step in the process before the government allows the drug to go to market. 

Before approval of the label, the FDA negotiates with the pharmaceutical company concerning its contents. After approval, the label appears in package inserts. It is published by the drug companies in the Physicians Desk Reference (PDR), a commercial book sent free to all practicing physicians and found in most treatment facilities and doctors offices. A shortened form of the label with emphasis on adverse effects must be included in advertising and promotional materials. 

The FDA-approved drug label is very important, especially in regard to defining dangerous side effects. Physicians often use the PDR to alert themselves to the dangers of drugs. Typically, it is the first place that physicians look when they have a question about a drug. Reviews in the literature are frequently based on it as well. 

Phase 4 spans the entire period of time after the drug has been approved and entered the market. Phase 4 studies are implemented when the FDA requests a drug company to examine newly discovered drug hazards. In my interviews with FDA officials, they agreed that this crucial 

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Proposed text of the labeling for the drug—Annotated Pharmacologic class, scientific rationale, intended use, and potential clinical Benefits... 

A) If information that is submitted under section 505(b) or (c) of the act and Sec. 314.53 is for a method of use patent, and the labeling for the drug product for which the applicant is seeking approval does not include any indications that are covered by the use patent, a statement explaining that the method of use patent does not claim any of the proposed indications. 

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