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Consensus Study Report

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years  (2011)

Proceedings

Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report  (2011)

Proceedings

Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop  (2017)

Proceedings

Challenges for the FDA: The Future of Drug Safety: Workshop Summary  (2007)

Consensus Study Report

Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks  (2009)

Proceedings

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report  (2010)

Proceedings

The Food and Drug Administration's Accelerated Approval Process for New Pharmaceuticals: Proceedings of a Workshop—in Brief  (2023)

Consensus Study Report

Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations  (2021)

Proceedings

Emerging Technologies and Innovation in Manufacturing Regenerative Medicine Therapies: Proceedings of a Workshop–in Brief  (2024)

Proceedings

The Food and Drug Administration's Emergency Use Authorization: Lessons Learned from the Past to Guide the Future: Proceedings of a Workshop–in Brief  (2021)

Consensus Study Report

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration  (2011)

Consensus Study Report

Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks  (2024)

Consensus Study Report

The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use  (2020)

Proceedings

Use of Meta-Analyses in Nutrition Research and Policy: Proceedings of a Workshop Series  (2024)

Consensus Study Report

Stronger Food and Drug Regulatory Systems Abroad  (2020)

Consensus Study Report

Premium Cigars: Patterns of Use, Marketing, and Health Effects  (2022)

Proceedings

Amyotrophic Lateral Sclerosis: Accelerating Treatments and Improving Quality of Life: Proceedings of a Workshop–in Brief  (2023)

Proceedings

Methadone Treatment for Opioid Use Disorder: Improving Access Through Regulatory and Legal Change: Proceedings of a Workshop  (2022)

Consensus Study Report

Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis  (2020)

Consensus Study Report

Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups  (2022)

Consensus Study Report

Ethical and Scientific Issues in Studying the Safety of Approved Drugs  (2012)

Proceedings

Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop  (2017)

Proceedings

Advancing Regulatory Science for Medical Countermeasure Development: Workshop Summary  (2011)

Proceedings

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary  (2012)

Consensus Study Report

Scientific Standards for Studies on Modified Risk Tobacco Products  (2012)

Proceedings

Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary  (2011)

Consensus Study Report

Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use  (2020)

Consensus Study Report

The Future of Drug Safety: Promoting and Protecting the Health of the Public  (2007)

Consensus Study Report

Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act  (2012)

Consensus Study Report

Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report  (2010)

Consensus Study Report

Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use  (2017)

Proceedings

Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary  (2014)

Consensus Study Report

Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration  (2005)

Consensus Study Report

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad  (2012)

Consensus Study Report

Enhancing Food Safety: The Role of the Food and Drug Administration  (2010)

Proceedings

Continuous Manufacturing for the Modernization of Pharmaceutical Production: Proceedings of a Workshop  (2019)

Consensus Study Report

Assessing the Use of Agent-Based Models for Tobacco Regulation  (2015)

Proceedings

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary  (2014)

Proceedings

Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary  (2007)

Proceedings

CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary  (2010)

Consensus Study Report

Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee  (2014)

Proceedings

The Drug Development Paradigm in Oncology: Proceedings of a Workshop  (2018)

Consensus Study Report

Animal Models for Assessing Countermeasures to Bioterrorism Agents  (2011)

Proceedings

Proceedings from the Workshop on Science-Based Assessment: Accelerating Product Development of Combination Medical Devices  (2004)

Proceedings

Implementing a National Cancer Clinical Trials System for the 21st Century: Second Workshop Summary  (2013)

Proceedings

Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop  (2019)

Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary  (2011)

Consensus Study Report

Front-of-Package Nutrition Rating Systems and Symbols: Promoting Healthier Choices  (2012)

Proceedings

The Safe Use Initiative and Health Literacy: Workshop Summary  (2010)

Consensus Study Report

The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies  (2013)