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
- Biosimilar safety factors in clinical practice Academic Article
- Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov Academic Article
- Content, Consistency, and Quality of Black Box Warnings: Time for a Change Academic Article
- Deep brain stimulation for hyperkinetic disorders 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 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
- 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
- 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
- Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone 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
- The FDA-mandated trial of safety of long-acting beta-agonists in asthma: finality or futility? Academic Article
- The Need for Additional Metrics to Assess Therapeutic Equivalence of Some Multiphasic Modified-Release Products 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
- 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
- What Is Involved in a Regulatory Trial Investigating a New Medical Device? Academic Article