United States Food and Drug Administration Concept

subject area of

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