The premise of this paper is a concern over the dismal record of approvals for biotechnology products despite the enormous resources poured into their development.The authors have described a number of issues which may help to explain the dearth of biotechnology product approvals. Included among those issues are suggestions for improving the development process by ensuring the presence of several key resources which may be overlooked by emerging biotechnology companies. Particularly, the authors advocate creative approaches to development rather than relying too strongly on approaches used in the past. A s well, the authors suggest that applicants should intelligently use the resources of the Food and Drug Administration (FDA) for guidance and input into the development process. Finally, the authors suggest that when both applicants and FDA work smarter and faster, there will be many more approvals of biotechnology products.
This article describes procedures used to prepare and maintain prescription drug labeling beginning with a brief overview of the statutory and regulatory requirements. Discussed is the labeling format prescribed by FDA regulation and the type of information needed for the key labeling components. The article provides a description of typical company approaches for developing and approving the labeling text. Discussed are the multi-disciplinary groups responsible for preparing and approving the copy with comparison to an analogous multi-disciplinary group at the FDA which has responsibility for review and approval of labeling submitted with regulatory documents. Discussed also is the need for international labeling consistency for drugs which are marketed in countries other than the U.S. Reference is made to security considerations regarding the approved copy.
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