Agency Guidance/Reports

Agency Guidance/Reports

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)
Guidance: Guidance for Industry Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
(March 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FDA, Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product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FDA, Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product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FDA, Draft Guidance for Industry Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009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)