Preclearance of Promotional Labeling; Clarification

Streszczenie

The Food and Drug Administration (FDA) is announcing that the Center for Biologics Evaluation and Research (CBER) is clarifying its policy regarding the preapproval of promotional labeling for biological products. In the November 1995 report issued by the President and Vice President, ``Reinventing the Regulation of Drugs Made from Biotechnology,'' FDA made a commitment to harmonize immediately CBER's requirements for the preapproval of promotional labeling with those of the Center for Drug Evaluation and Research (CDER) under which a company may submit such information to the agency at the time the company disseminates it. This notice is issued to clarify that FDA has fulfilled the commitment to allow industry to submit promotional labeling to CBER at the time of initial dissemination. Sponsors need not wait for approval from CBER before using promotional labeling.