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All manufacturers and distributors of prescription pharmaceutical products in theUnited States who hold an approved New Drug Application (hereinafter “NDA”) oran Abbreviated New Drug Application (hereinafter “ANDA”) have an independentobligation to inform and warn doctors and patients on how to use a drug, have aduty in maintaining a label that is current with scientific and medicalinformation to advise use, providing comprehensive responses to inquiries fromhealth professionals and patients, and promoting safe use through marketing andsales practices. If a drug company learns of a new adverse event associatedwith its drug or of a change in the risk of a particular adverse event, thatdrug company can change its label to reflect that change in adverse event priorto FDA approval. Specifically,there’s a specific regulation which is fondly known as 314.70(c). This regulation, in the industry isreferred to as a change being effected. What it does is that for certain things in the label such as safety, itallows a drug company to make the safety change and notify FDA at the time itimplements it so it can actually print a new label, send a copy to the FDA andprotect American consumers.

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