United States Food and Drug Administration
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Helicobacter pyloriInfection Academic Article
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A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results Academic Article
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A review of the two major regulatory pathways for non-proprietary low-molecular-weight heparins Academic Article
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A systematic review of validated methods for identifying orthopedic implant removal and revision using administrative data Academic Article
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American Society of Clinical Oncology Policy Brief: FDA’s Regulation of Electronic Nicotine Delivery Systems and Tobacco Products Academic Article
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An Open Letter to Health Canada Academic Article
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Availability of Safe and Effective Therapeutic Options to Pregnant and Lactating Individuals Following the United States Food and Drug Administration Pregnancy and Lactation Labeling Rule Academic Article
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Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making Academic Article
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Clinical Trial Considerations in Developing Treatments for Early Stages of Common, Chronic Kidney Diseases: A Scientific Workshop Cosponsored by the National Kidney Foundation and the US Food and Drug Administration Conference Paper
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Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 Academic Article
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Clinical and Technical Considerations for Brain PET Imaging for Dementia Academic Article
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Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov Academic Article
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Conflicting verdicts on peanut oral immunotherapy from the Institute for Clinical and Economic Review and US Food and Drug Administration Advisory Committee: Where do we go from here? Academic Article
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Controversies Around Measuring Drug Toxicity: US Food and Drug Administration and Gastrointestinal Perspectives Academic Article
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Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report Academic Article
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FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper Academic Article
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Global Myeloma Trial Participation and Drug Access in the Era of Novel Therapies Conference Paper
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Helicobacter pylori infection. Academic Article
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How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure Academic Article
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INDs for PET Molecular Imaging Probes—Approach by an Academic Institution Academic Article
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Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus Academic Article
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Is the dose of warfarin prescribed by American physicians unnecessarily high? Academic Article
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Kinetics of in Vitro Lactoferrin Deposition on Silicone Hydrogel and FDA Group II and Group IV Hydrogel Contact Lens Materials Academic Article
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Kinetics ofIn VitroLysozyme Deposition on Silicone Hydrogel, PMMA, and FDA Groups I, II, and IV Contact Lens Materials Academic Article
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Model‐Informed Drug Development for Anti‐Infectives: State of the Art and Future Academic Article
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National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group Report Academic Article
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New Orthopedic Devices and the FDA Academic Article
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Nonculture Tests for Genital Tract Chlamydial Infection Academic Article
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Overview of Olestra: A New Fat Substitute Academic Article
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Patient-Dependent and Material-Dependent Factors in Contact Lens Deposition Processes Conference Paper
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Phase 4 research: what happens when the rubber meets the road? Academic Article
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Proceedings of a Consensus Conference: Pathogen Inactivation—Making Decisions About New Technologies Academic Article
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Proceedings of a Consensus Conference: Risk-Based Decision Making for Blood Safety Academic Article
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Proposed Regulatory Framework for Direct-to-Consumer Genetic Testing: Diagnostics vs Genetic Screening Academic Article
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Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes? Academic Article
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Response to Maubach and Hoek's paper on GP attitudes to DTCA. Academic Article
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Safety of Long-Acting β-Agonists Academic Article
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Scientists' Statement Regarding Data on the Sodium-Hypertension Relationship and Sodium Health Claims on Food Labeling Academic Article
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Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020 Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021 Academic Article
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The Advisory Committee on Immunization Practices’ Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines — United States, 2021 Academic Article
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The FDA-mandated trial of safety of long-acting beta-agonists in asthma: finality or futility? Academic Article
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The United States Food and Drugs Administration Approves a Generic Enoxaparin Academic Article
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The need for change Academic Article
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Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords Academic Article
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Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance Academic Article
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Trends in paediatric clinical pharmacology data in US pharmaceutical labelling Academic Article
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Trends in pregnancy labeling and data quality for US-approved pharmaceuticals Academic Article
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US FDA Breast Implant Postapproval Studies Academic Article
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Undetectable Concentrations of a Food and Drug Administration-approved High-sensitivity Cardiac Troponin T Assay to Rule Out Acute Myocardial Infarction at Emergency Department Arrival Academic Article
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Update from the Canadian Dyspepsia Working Group. Academic Article
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Use of Ebola Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020 Academic Article
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What Is Involved in a Regulatory Trial Investigating a New Medical Device? Academic Article