ex·clu·sivi·ty (n.) – period of uniqueness, typically accompanied by envy and profit
FDA recognizes data and market exclusivity in its drug approval process, which emanated from laws encouraging the development of drugs for rare diseases and allowing for generic drugs, although the terms themselves do not appear in the bills.
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Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.