subject area of
- 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
- 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
- Helicobacter pyloriInfection 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
- 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
- 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 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
- 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