Characteristics and Outcomes of Products Seeking Competitive Generic Therapy Designation and Exclusivity.
retrospective_cohort · Level III
Where this comes from
- Record sourced from PubMed, PMID 34751720.
- Also identified by DOI 10.1001/jama.2021.14595 and PMC identifier 8579229.
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Abstract
This study describes the process used by the US Food and Drug Administration to review potential generic drugs for Competitive Generic Therapy (CGT) designation and marketing exclusivity as well as the characteristics and outcomes of products that have sought CGT designation and exclusivity from 2017-2020.
Medical subject headings
- Drug Approval
- Drugs, Generic