Article
Computer Science, Interdisciplinary Applications
Betuel Diler Kilic, Oezgen Karaer, Ismail S. Bakal
Summary: We analyze the pricing and ordering decisions in a two-echelon supply chain with partially substitutable products. Our findings show that increasing spillover rates intensify price competition between manufacturers and mitigate the double marginalization effect in the supply chain.
COMPUTERS & INDUSTRIAL ENGINEERING
(2022)
Editorial Material
Medicine, General & Internal
Neal L. Benowitz, Kenneth E. Warner, Matthew L. Myers, Dorothy Hatsukami, Micah L. Berman, Donna Vallone, Joanna E. Cohen
Summary: The FDA has the potential to promote the development and availability of smoking cessation aids that are both effective and desired by consumers, thereby significantly benefiting public health.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Review
Clinical Neurology
Robert Herrmann, Maureen Dreher, Andrew Farb, Michael Hoffmann, Christopher M. Loftus, Nina Mezu-Nwaba, Vivek Pinto, Xiaolin Zheng, Carlos Pena
Summary: This article discusses the efforts made by the US FDA Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of neurological devices. The FDA has developed best practices and encouraged developers to conduct their studies in the US, using various regulatory approaches such as early engagement with sponsors, in-depth interaction during the review phase, and provision of an FDA toolkit.
JOURNAL OF NEUROSURGERY
(2022)
Article
Environmental Sciences
Huida Zhao, Jiaguo Liu, Pengfei Zhao, Jihong Chen
Summary: This research examines the technology-enabled ways to resolve conflict between domestic products and polluted products through a game model, and analyzes the motivations behind the presence of polluted products in the market and the changes in market share for domestic products.
MARINE POLLUTION BULLETIN
(2022)
Review
Medicine, General & Internal
Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim
Summary: Medical device regulation in the US has become more complex over the past 45 years, with various regulatory pathways and evolving evidence requirements. Increased FDA support from industry and concerns about flexible authorization requirements highlight the ongoing tension between efficient access and ensuring patient safety.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2021)
Article
Biology
Merriline M. Satyamitra, Zulmarie Perez-Horta, Andrea L. DiCarlo, David R. Cassatt, Carmen Rios, Paul W. Price, Lanyn P. Taliaferro
Summary: The Radiation and Nuclear Countermeasures Program is responsible for assessing injuries caused by radiation exposure and providing medical countermeasures. They organized a workshop to evaluate research devices, discuss government policies, regulatory considerations, and lessons learned.
RADIATION RESEARCH
(2022)
Article
Mathematics, Interdisciplinary Applications
Jie Xing, Taoshun He
Summary: This paper examines an optimal stock liquidation problem over a finite-time horizon, modeling it as an optimal stopping problem in a regime-switching market and providing a numerical approach to finding the optimal stopping time. The results offer insights into the optimal stock liquidation strategy under specific conditions, along with a numerical implementation approach.
DISCRETE DYNAMICS IN NATURE AND SOCIETY
(2021)
Article
Substance Abuse
Shannon M. Melody, Veronica A. Martin-Gall, Mark G. Veitch
Summary: The study reveals various reasons that lead retailers to stop selling tobacco, mainly driven by business considerations with health or ethical factors playing a minor role. Most retailers believe they have little impact in mitigating tobacco-related harm.
Article
Chemistry, Medicinal
Priyadeep Bhutani, Gaurav Joshi, Nivethitha Raja, Namrata Bachhav, Prabhakar K. Rajanna, Hemant Bhutani, Atish T. Paul, Raj Kumar
Summary: This study compiled and analyzed 245 drugs approved by the U.S. FDA from 2015 to June 2020, focusing on cancer, infectious diseases, neurological conditions, and genetic, metabolic, cardiovascular disorders. The analysis also looked at the structural, elemental, and functional group diversity among the approved drugs, as well as drug-likeness for the approved drugs.
JOURNAL OF MEDICINAL CHEMISTRY
(2021)
Article
Engineering, Multidisciplinary
Danna Chen, Yong-Wu Zhou, Xiaogang Lin, Qiang Lin, Wenhui Fu
Summary: This study examines the interaction between an intermediary's information sharing and a manufacturer's selling format selection, finding that the manufacturer should choose different selling models based on the fee and competition intensity, while the intermediary's information-sharing behavior is influenced by the fee and selling format decision.
JOURNAL OF INDUSTRIAL AND MANAGEMENT OPTIMIZATION
(2023)
Article
Engineering, Multidisciplinary
Danna Chen, Yong-Wu Zhou, Xiaogang Lin, Qiang Lin, Wenhui Fu
Summary: In practice, manufacturers can sell products through intermediaries via reselling or agency selling, or employ a hybrid selling approach. We develop a game-theoretic model to study the impact of intermediary's information-sharing on a manufacturer's selling format selection. The results show that the manufacturer should adopt reselling (hybrid selling) if the proportional fee is relatively large (small) and the intermediary should voluntarily share information if the fee is intermediate.
JOURNAL OF INDUSTRIAL AND MANAGEMENT OPTIMIZATION
(2023)
Article
Substance Abuse
Abby L. Smith, Seema Mihrshahi, Veronica A. Martin-Gall, Marina Brkic, Mark G. Veitch, Becky Freeman
Summary: This study investigates the feasibility of a non-regulatory intervention to encourage low volume tobacco retailers to stop selling. The findings suggest that this intervention may help to reduce the retail availability of tobacco.
Editorial Material
Biochemistry & Molecular Biology
Kushal T. Kadakia, Adam L. Beckman, Harlan M. Krumholz
Summary: The US Food and Drug Administration should take action to combat health misinformation by updating product labeling, investing in monitoring and addressing the internet and social media's influence.
Review
Oncology
Shaily Arora, Preeti Narayan, Christy L. Osgood, Suparna Wedam, Tatiana M. Prowell, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Soma Ghosh, Reena Philip, Gwynn Ison, Tara Berman, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Summary: The treatment of patients with breast cancer has been greatly influenced by the approval of various drugs and indications in the past decade. This article summarizes the FDA approvals of 30 treatments for breast cancer from 2010 to 2020, including trial design, results, and regulatory considerations. The majority of approvals were for metastatic breast cancer, with a smaller number for early breast cancer. These approvals were primarily based on progression-free survival, overall survival, or objective response rate, and also involved other review initiatives and designations.
CLINICAL CANCER RESEARCH
(2022)
Review
Oncology
Shaily Arora, Preeti Narayan, Gwynn Ison, Tara Berman, Daniel L. Suzman, Suparna Wedam, Tatiana M. Prowell, Soma Ghosh, Reena Philip, Christy L. Osgood, Jennifer J. Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Christina Brus, Erik W. Bloomquist, Mallorie H. Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A. Beaver
Summary: There has been significant progress in the treatment of gynecologic cancers over the past decade. This article summarizes the FDA approvals for gynecologic cancer treatments from 2010 to 2020, totaling 17 new indications. Six of these indications received accelerated approval, while 11 received regular approval. The approval decisions were supported by primary efficacy endpoints and showed a favorable benefit-risk profile. The article also discusses the current FDA thinking on drug development opportunities and regulatory initiatives.
CLINICAL CANCER RESEARCH
(2022)