NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Subjects Quality Control Remove constraint Subjects: Quality Control

Search Results

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

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

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

4. Bioanalytical method validation

6. Quality attribute considerations for chewable tablets

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

9. 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

10. Implementing the Affordable Care Act: key design decisions for state-based exchanges