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5. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101713224-pdf

6. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101713268-pdf

7. Improving the safety of the blood transfusion process

nlm:nlmuid-101546441-pdf

8. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

nlm:nlmuid-101734070-pdf

9. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

nlm:nlmuid-101734078-pdf

10. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

nlm:nlmuid-101734165-pdf