Letter--Draft FDA Guidance "Considerations in Demonstrating Interchangeability with a Reference Product": Overview and Presentation-Related Concerns.
editorial · Level V
Where this comes from
- Record sourced from PubMed, PMID 28230453.
- Also identified by DOI 10.18553/jmcp.2017.23.3.266 and PMC identifier 10398053.
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Abstract
Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.
Medical subject headings
- Biological Products
- Biosimilar Pharmaceuticals
- Drug Industry