Regulatory and Scientific Issues Related to
Developing
Follow-On Protein Products
During the past several years, there has been increasing interest in the development of follow-on protein products in light of advances in manufacturing technology, process control, and protein characterization. We use the informal term follow-on protein products generally to refer to proteins and peptides that are intended to be sufficiently similar to a product already approved under the Federal Food, Drug, and Cosmetic Act or licensed under the Public Health Service Act to permit the applicant to rely on certain existing scientific knowledge about the safety and effectiveness of the approved protein product. Follow-on protein products may be produced through biotechnology or derived from natural sources. FDA has been considering the circumstances in which review and approval of follow-on protein products may be appropriate.
This Web page provides a compilation of presentations, citizen petitions and related documents, and public comments on scientific and regulatory issues related to the development of follow-on protein products. Additional documents and information will be added as they become available.
Public Workshops
Scientific Issues in Assessing the Similarity of Follow-on Protein Products
December 12-14, 2005
Co-sponsored by FDA, in collaboration with the National Institute for Standards and
Technology, and the New York Academy of Sciences
Follow-On Protein Pharmaceuticals
February 14-16, 2005
Co-sponsored by FDA and the Drug Information Association
Scientific Considerations Related to Developing Follow-On Protein
Products
September 14-15, 2004
Sponsored by FDA
Citizen Petitions and Responses
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Date created: June 6, 2006 |