Approval times for supplemental indications for recombinant proteins

This new study shows that, in the US, approval of supplemental indications for recombinant protein products takes an average of seven months longer than approval of the original indication.

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Bibliographic Details
Published in:Nature biotechnology 1997-02, Vol.15 (2), p.130-134
Main Authors: Gosse, Marilyn E., Nelson, Toben F.
Format: Article
Language:English
Subjects:
Agriculture
Bioinformatics
Biological and medical sciences
Biomedical and Life Sciences
Biomedical Engineering/Biotechnology
Biomedicine
Biotechnology
Biotechnology - legislation & jurisprudence
Drug Industry - legislation & jurisprudence
feature
General pharmacology
Genetic Engineering
Humans
Life Sciences
Medical sciences
Miscellaneous
Neoplasms - therapy
Orphan Drug Production - legislation & jurisprudence
Pharmacology. Drug treatments
Recombinant Proteins - therapeutic use
Time Factors
United States
United States Food and Drug Administration
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Description
Summary:This new study shows that, in the US, approval of supplemental indications for recombinant protein products takes an average of seven months longer than approval of the original indication.
ISSN:1087-0156
1546-1696
DOI:10.1038/nbt0297-130