Protropin status questioned by FDA decision
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چکیده
منابع مشابه
In U.S., biosimilars still await FDA decision.
Offi cials at the U.S. Food and Drug Administration have yet to announce if and when they plan to begin accepting abbreviated applications for follow-on biologics (referred to as " biosimilar " drugs in Europe), but experts said they do not expect anything from the agency soon. Generic biologic agents can still be approved through a new-drug application (NDA), but the burden of proof that comes...
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ژورنال
عنوان ژورنال: Nature
سال: 1987
ISSN: 0028-0836,1476-4687
DOI: 10.1038/326231c0