United States Food and Drug Administration Concept

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Helicobacter pyloriInfection Journal Articles
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 Journal Articles
A review of the two major regulatory pathways for non-proprietary low-molecular-weight heparins Journal Articles
A systematic review of validated methods for identifying orthopedic implant removal and revision using administrative data Journal Articles
American Society of Clinical Oncology Policy Brief: FDA’s Regulation of Electronic Nicotine Delivery Systems and Tobacco Products Journal Articles
An Open Letter to Health Canada Journal Articles
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 Journal Articles
Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making Journal Articles
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 Conferences
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 Journal Articles
Clinical and Technical Considerations for Brain PET Imaging for Dementia Journal Articles
Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov Journal Articles
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? Journal Articles
Controversies Around Measuring Drug Toxicity: US Food and Drug Administration and Gastrointestinal Perspectives Journal Articles
Equivalence Considerations for Orally Inhaled Products for Local Action—ISAM/IPAC-RS European Workshop Report Journal Articles
Evaluating Cost-Effectiveness: An Essential Part of New Cancer Drug Approvals Journal Articles
Exclusive Drug Labeling Rights as a New Incentive for Contribution to a Communal Biomarker Resource Journal Articles
FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper Journal Articles
Global Myeloma Trial Participation and Drug Access in the Era of Novel Therapies Conferences
Helicobacter pylori infection. Journal Articles
How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure Journal Articles
INDs for PET Molecular Imaging Probes—Approach by an Academic Institution Journal Articles
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus Journal Articles
Is the dose of warfarin prescribed by American physicians unnecessarily high? Journal Articles
Kinetics of in Vitro Lactoferrin Deposition on Silicone Hydrogel and FDA Group II and Group IV Hydrogel Contact Lens Materials Journal Articles
Kinetics ofIn VitroLysozyme Deposition on Silicone Hydrogel, PMMA, and FDA Groups I, II, and IV Contact Lens Materials Journal Articles
Model‐Informed Drug Development for Anti‐Infectives: State of the Art and Future Journal Articles
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 Journal Articles
New Orthopedic Devices and the FDA Journal Articles
Nonculture Tests for Genital Tract Chlamydial Infection Journal Articles
Overview of Olestra: A New Fat Substitute Journal Articles
Patient-Dependent and Material-Dependent Factors in Contact Lens Deposition Processes Conferences
Phase 4 research: what happens when the rubber meets the road? Journal Articles
Proceedings of a Consensus Conference: Pathogen Inactivation—Making Decisions About New Technologies Journal Articles
Proposed Regulatory Framework for Direct-to-Consumer Genetic Testing: Diagnostics vs Genetic Screening Journal Articles
Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes? Journal Articles
Response to Maubach and Hoek's paper on GP attitudes to DTCA. Journal Articles
Safety of Long-Acting β-Agonists Journal Articles
Scientists' Statement Regarding Data on the Sodium-Hypertension Relationship and Sodium Health Claims on Food Labeling Journal Articles
Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies Journal Articles
Targeting of human cancer stem cells predicts efficacy and toxicity of FDA-approved oncology drugs Journal Articles
The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020 Journal Articles
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 Journal Articles
The Advisory Committee on Immunization Practices’ Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines — United States, 2021 Journal Articles
The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs Journal Articles
The FDA-mandated trial of safety of long-acting beta-agonists in asthma: finality or futility? Journal Articles
The United States Food and Drugs Administration Approves a Generic Enoxaparin Journal Articles
The need for change Journal Articles
Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords Journal Articles
Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance Journal Articles
Trends in paediatric clinical pharmacology data in US pharmaceutical labelling Journal Articles
Trends in pregnancy labeling and data quality for US-approved pharmaceuticals Journal Articles
US FDA Breast Implant Postapproval Studies Journal Articles
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 Journal Articles
Update from the Canadian Dyspepsia Working Group. Journal Articles
Use of Ebola Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020 Journal Articles
What Is Involved in a Regulatory Trial Investigating a New Medical Device? Journal Articles