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 FDA’s Guidance for Industry on Blood Establishment Computer System Validation in the User’s Facility – 5/8/13
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