A5010934319- Pharmaceutical Economics and Policy
- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Quality and Counterfeiting
- Biomedical Ethics and Regulation
- Pharmaceutical industry and healthcare
- Pharmaceutical studies and practices
- Biotechnology and Related Fields
- Biomedical and Engineering Education
- Global Maternal and Child Health
- Viral Infections and Outbreaks Research
- Atrial Fibrillation Management and Outcomes
- Vaccine Coverage and Hesitancy
- Health and Medical Research Impacts
- Global Security and Public Health
- Global Public Health Policies and Epidemiology
- Healthcare Policy and Management
- Pharmacogenetics and Drug Metabolism
- HIV, Drug Use, Sexual Risk
- Psychiatric care and mental health services
- Healthcare Decision-Making and Restraints
- Computational Drug Discovery Methods
- Safe Handling of Antineoplastic Drugs
- HIV/AIDS Research and Interventions
- Biosimilars and Bioanalytical Methods
- Pharmacovigilance and Adverse Drug Reactions
Gates Foundation
2015-2025
United States Food and Drug Administration
2000-2012
Center for Drug Evaluation and Research
1994-2000
The removal of 5 pharmaceuticals from the market in a 12-month period because unexpected adverse events raised concerns about adequacy drug review process at US Food and Drug Administration (FDA). Specifically, were improvements efficiency that significantly reduced FDA times. We have reviewed circumstances removals to determine whether there was any relationship increased efficiencies process. When removed drugs analyzed by date approval, no increase number taken off seen, demonstrating...
Deputy Center Director (Review Management), for Drug Evaluation and Research."Subject: Reports of epidural or spinal hematomas with the concurrent use low molecular weight heparin spinal/epidural anesthesia puncture"Dear Health Care Professional:The Food Administration (FDA) would like to call your attention recent postmarketing reports patients who have developed puncture. Many caused neurologic injury, including long-term permanent paralysis. Because these events were reported voluntarily...
The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name AL should be broadened. Against this background ongoing debate, we examine environmental changes will likely make pathways preferred approach in future. key drivers include: growing patient demand for timely access to promising therapies, emerging science leading fragmentation treatment populations, rising payer influence on product...
Journal Article Safety alert: Hazards of precipitation associated with parenteral nutrition Get access Murray M. Lumpkin Search for other works by this author on: Oxford Academic Google Scholar American Hospital Pharmacy, Volume 51, Issue 11, 1 June 1994, Pages 1427–1428, https://doi.org/10.1093/ajhp/51.11.1427 Published: 01 1994
Background The United Nations Millennium Development Goals galvanized global efforts to alleviate suffering of the world's poorest people through unprecedented public-private partnerships. Donor aid agencies have demonstrably saved millions lives that might otherwise been lost disease increased access quality-assured vaccines and medicines. Yet, introduction these health interventions in low- middle-income countries (LMICs) continues face a time lag due factors which remain poorly...
Substandard and falsified medical products (including medicines, vaccines, biologics, diagnostics1World Health OrganizationWHO Global Surveillance Monitoring System for substandard products. World Organization, Geneva2017http://apps.who.int/medicinedocs/en/m/abstract/Js23373en/Date accessed: October 16, 2019Google Scholar) represent a significant growing threat to human health. result from errors, corruption, negligence, or poor practice in manufacturing, procurement, regulation,...
Substandard and falsified medicines in Africa are a major public health concern. Access to quality medical products African countries is governed large part by two entities at the national level: regulatory authority procurement agency. The importance of regulators ensuring well known. interplay between regulator agency also has significant impact on access but less understood. This study's aim was characterise regulatory-procurement interface - intersection decision-making these spheres...
Background: Ensuring access to affordable, high-quality pharmaceuticals is essential for global health. However, regulatory requirements vary significantly across markets, influencing manufacturing costs, drug prices, and quality medicines. This study examines cost variations in pharmaceutical India products destined three distinct markets: the United States (highly regulated), World Health Organization (WHO) Prequalification (regulatory stringency comparable many Lower- Middle-Income...
An Omani infant boy who presented in the neonatal period with cardiac failure secondary to hypertrophic cardiomyopathy is reported. He subsequently progressed show features of a metabolic disorder multisystem involvement and was diagnosed have Type II glycogenosis (Pompe9s disease). The differential diagnosis management are outlined.
Access to affordable, high-quality medicines, vaccines, and medical devices is critical patients in resource-limited settings. For the past 23 years, World Health Organization Prequalification Program (WHOPQ) has provided procurers with a rigorous assessment of quality these products. As number important products soared, resources WHOPQ program are being strained. Advances field clinical pharmacology could help meet increased demand on this program. With support from multiple international...
The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose address this gap by reengineering processes accelerate reliable delivery products that unmet medical needs. Adaptive (ABI) provides an integrative, strategic approach for process innovation. Although the term “ABI” new, it encompasses fragmented “tools” have been developed across global pharmaceutical industry, and could evolution through more coordinated application. ABI involves...