Abstract
Draft FDA guidance would reduce barriers to marketing high-quality generic insulin in the United States by declaring that the evidence necessary for proving an insulin product "highly similar" to an existing product is sufficient for designating it as interchangeable.
Original language | English (US) |
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Pages (from-to) | 981-983 |
Number of pages | 3 |
Journal | New England Journal of Medicine |
Volume | 382 |
Issue number | 11 |
DOIs | |
State | Published - Mar 12 2020 |
ASJC Scopus subject areas
- Medicine(all)