Package Insert

The content and format of the package insert is outlined in FDA regulations (Fig. 7.25). The package insert must contain the following sections: description, clinical pharmacology, indications and usage, contraindications, warnings, precau-

r Package insert (PI): o Content and format established by regulations o Annotated product label is in registration submission o Negotiation of language is one of last tasks of submission review o Basis for language used in advertising copy r Advertising copy: r Content and presentation established by regulations o Cannot be false or misleading o Must contain "fair balance"of benefits and risks o Advertising campaign submitted for FDA clearance

Fig. 7.25. Negotiating Product Labeling and Advertising Copy tions, adverse reactions, drug abuse and dependence, over-dosage, dosage and administration and how supplied. Proposed labeling must be submitted at the time of the NDA/BLA/ANDA filing. The package insert must accurately reflect the data generated during drug development, and claims in the label must be supported by data. To better assist the FDA in substantiating the claims made in the package insert, an annotated version is provided in the submission. All information in the package insert must be cross-referenced to the appropriate section of the submission that supports the labeling statement. Depending on the type of product, a sponsor may elect to develop a patient package insert, which assists patients with product usage and also requires FDA review and approval.

As discussed previously, labeling negotiations between FDA and the sponsor are usually not initiated until the product review is substantially complete. It is typically the last action step on the critical path prior to FDA approval. The package insert forms the basis for what can, and very importantly, what cannot, be said in advertising and promotional material and used by the sales organization. Based on the importance of the wording in the package insert to the commercial success of the product, sponsors may often elect to continue to negotiate the labeling instead of opting for a more prompt product approval with less than desirable labeling. For example, a phrase like "arrests disease progression" versus "slows disease progression" will have significant impact on provider acceptance and the marketing strategy. The package insert creates the opportunities and limits for marketing a product.

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Defeat Drugs and Live Free

Defeat Drugs and Live Free

Being addicted to drugs is a complicated matter condition that's been specified as a disorder that evidences in the obsessional thinking about and utilization of drugs. It's a matter that might continue to get worse and become disastrous and deadly if left untreated.

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