Agency Guidance/Reports
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Guidance: Open Payments Creating Public Transparency into Industry-Physician Financial Relationships
(June 2014) -
Guidance: Open Payments Creating Public Transparency into Industry-Physician Financial Relationships
(July 2013) - FDA, Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
(February, 15, 2012) - FDA, Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
(February 15, 2012) - FDA, Draft Guidance for Industry Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
(February 15, 2012) - CBO Analysis of Affordable Care Act Effects on Prescription Drug Prices
(November 4, 2010)