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1. The NIH-led research response to COVID-19

2. Update on and Future Directions for Use of Anti–SARS-CoV-2 Antibodies: National Institutes of Health Summit on Treatment and Prevention of COVID-19

3. Benefits of Streamlined Point-of-Care Trial Designs: Lessons Learned From the UK RECOVERY Study

4. Food and Drug Administration Beyond the 2001 Government Accountability Office Report: Promoting Drug Safety for Women

5. Progress and opportunities for women in clinical trials: A look at recent data and initiatives from the U.S. FDA

7. Patient-Centered Approach to Benefit–Risk Characterization Using Number Needed to Benefit and Number Needed to Harm: Advanced Non–Small-Cell Lung Cancer

8. New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact

9. FDA Initiative for Drug Facts Label for Over-the-Counter Naloxone

11. Reducing Sodium Intake in the US: Healthier Lives, Healthier Future

12. Integrating Research into Community Practice - Toward Increased Diversity in Clinical Trials

13. MAQC and the era of genomic medicine

14. MAQC and the era of genomic medicine

15. Association of plasma YKL-40 with brain amyloid-β levels, memory performance, and sex in subjective memory complainers

16. Bridging the Gap at Warp Speed — Delivering Options for Preventing and Treating Covid-19

17. Audio Interview: An Update from Operation Warp Speed

20. Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

21. Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

22. Trends in COVID-19 therapeutic clinical trials

23. Toward Better-Quality Compounded Drugs — An Update from the FDA

24. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both

25. Biosimilars: The US Regulatory Framework

26. The FDA and the Next Wave of Drug Abuse — Proactive Pharmacovigilance

27. Drug Regulation in the Era of Individualized Therapies

28. Plasma amyloid β 40/42 ratio predicts cerebral amyloidosis in cognitively normal individuals at risk for Alzheimer's disease

29. Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma

30. Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma

31. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality

32. A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer

33. The US regulatory and pharmacopeia response to the global heparin contamination crisis

34. Center for Drug Evaluation and Research Perspective on Quality in Clinical Trials

35. Value Assessment in the Regulatory Context

36. Integrated Drug Reviews at the US Food and Drug Administration

37. Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

38. Medication development in opioid addiction: Meaningful clinical end points

39. Precision pharmacology for Alzheimer's disease

40. FDA pharmaceutical quality oversight

41. Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

42. Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

43. Impact of the US FDA 'Biopharmaceutics Classification System' (BCS) Guidance on Global Drug Development

44. A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma

45. Understanding Pharmaceutical Quality by Design

46. The FDA's Approach to the Prescription Opioid Problem

48. 'Precision' drug development?

49. Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases

50. The PCAST Report on Pharmaceutical Innovation: Implications for the FDA

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