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Regulatory/Government Affairs Analysis and Summary

This section includes analyses of documents on general regulatory and legislative topics. Analyses of documents related to other issues can be found within the individual sections accessible through the main regulatory/government affairs landing page.

Analysis of “Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products” Final Rule – 04/04/19

Summary of CBER’s Interim Strategic Plan FY2017-19, Published 17 October 2016 - 10/17/16

Analysis of the Final Rule on Requirements for Blood and Blood Components – 7/14/15

President and House Republicans Offer Conflicting Budgets – Cuts to Many Health Care Programs Inevitable – 2/16/11

Analysis of Guidance on Process Validation – 2/15/11