Union Catalogue of Belgian Libraries
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Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production.
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Guidance for industry : Prescription Drug Marketing Act (PDMA) requirements, questions and answers.
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Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
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Guidance for industry : nonclinical safety evaluation of pediatric drug products.
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Guidance for industry : Prescription Drug Marketing Act, donation of prescription drug samples to free clinics.
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Guidance for industry : antiviral product development, conducting and submitting virology studies to the agency.
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Guidance for industry : public availability of labeling changes in "changes being effected" supplements.
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From test tube to patient : protecting America's health through human drugs.
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Guidance for industry and review staff : recommended approaches to integration of genetic toxicology study results.
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Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
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