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Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products
1996
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Electronic and Book
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Guidance for industry : Q1B photostability testing of new drug substances and products
1996
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Guidance for industry : Q2B validation of analytical procedures, methodology
1996
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Guidance for industry : Q1C stability testing for new dosage forms
1996
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Guideline for industry : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility
1996
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Annual performance report, Prescription Drug User Fee Act of 1992 fiscal year : ... report to Congress
1995
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Guidance for industry : content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
1995
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A review of FDA's implementation of the Drug Export Amendments of 1986
1990
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Annual report
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Center for Biologics Evaluation and Research (U.S.)
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Joyner - Microforms B300
Call Number:
HE 20.4801
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