Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Technical Amendment

摘要

The Food and Drug Administration (FDA) is amending certain regulations regarding biological products to include references to the Center for Drug Evaluation and Research (CDER) or the Director, CDER, and to include CDER address information or updated CDER address information, where appropriate. FDA is also amending the regulations to update mailing address information including mailing codes for the Center for Biologics Evaluation and Research (CBER), and to place the current mailing addresses for certain biologics regulations in a single location. These changes, among others, are being taken to reflect the reorganization between CBER and CDER due to the transfer of responsibility for certain products from CBER to CDER, and to ensure the consistency and accuracy of the regulations.