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Original Artikel |
Datum |
Titel |
Autoren Alle Autoren |
| 1 |
[GO] |
2025―Okt―10 |
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016-2023) |
Yoseok Park, Kyenghee Kwon |
| 2 |
[GO] |
2025―Sep―06 |
Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews |
Zilke Claessens, Grace Beirne, Catherine Decouttere, Nico Vandaele, Liese Barbier, Isabelle Huys |
| 3 |
[GO] |
2025―Sep―06 |
The Use of Unmanned Aerial Vehicles (UAV) on Delivering Biological Samples for COVID-19 and Tuberculosis Diagnosis: A Scoping Review |
Olga Maíra Machado Rodrigues, Izabela Gimenes Lopes, Mariah Eduarda Ferreira de Oliveira, Mônica Angélica Carreira Fragoso, Maria Regina Fernandes de Oliveira, Raquel Santos Silva, et al. (+3) Glaura Regina de Castro e Caldo Lima, Amílcar Sabino Damazo, Wagner de Jesus Martins |
| 4 |
[GO] |
2025―Mrz―18 |
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private-Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE Generation |
Nicolle M. Gatto, Elizabeth M. Garry, Melanie Wang, Névine Zariffa, Laura Roe, Aloka Chakravarty, Donna Rivera |
| 5 |
[GO] |
2024―Jun―24 |
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency |
Marijo Kambere, Hong Vu, Dana Kappel, Kukhwa Oh, Philip Budashewitz, John Concato |
| 6 |
[GO] |
2024―Apr―29 |
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies |
Zhi-Hui Song, Qiao-Ming Huang, Shan-Shan Xu, Jian-Bo Zhou, Chao Zhang |
| 7 |
[GO] |
2023―Okt―20 |
Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations |
Marina Ghadanian, Ellen Schafheutle |
| 8 |
[GO] |
2023―Jun―02 |
Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future-An Industry View |
Gaia Geraci, Janis Bernat, Céline Rodier, Virginia Acha, Jaqueline Acquah, Ginny Beakes-Read |
| 9 |
[GO] |
2023―Mrz―28 |
Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru |
Percy Herrera-Añazco, Diego Urrunaga-Pastor, Suly Soto-Ordoñez, Fernando Torres, Luis Manuel López Dávila, Agueda Muñoz del Carpio Toia |
| 10 |
[GO] |
2022―Okt―30 |
Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events |
Hidetaka Kobayashi, Sayoko Fukuda, Rina Matsukawa, Yumi Asakura, Yuri Kanno, Tomohiro Hatta, et al. (+12) Yurina Saito, Yuki Shimizu, Shuichi Kawarasaki, Mari Kihara, Natsumi Kinoshita, Hikari Umeda, Tatsuya Noda, Tomoaki Imamura, Yuichi Nishioka, Toshihiro Yamaguchi, Shuichiro Hayashi, Toyotaka Iguchi |
| 11 |
[GO] |
2022―Sep―29 |
Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward |
Sannie Siaw Foong Chong, Masaaki Kanno, Alice Seat Mee Chee, Siew Mei Long, Stephanie Hui Min Ong, Usanee Harnpramukkul, Richard Simon R. Binos |
| 12 |
[GO] |
2022―Sep―15 |
Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story |
Hanine Abbas, Abeer Zeitoun, Myriam Watfa, Rita Karam |
| 13 |
[GO] |
2022―Feb―11 |
Ivermectin in COVID-19: The Case for a Moratorium on Prescriptions |
Andreea Molnar, Stephanie Lau, Maja Berges, Raymond B. Masa, Joshua J. Solano, Scott M. Alter, et al. (+5) Lisa M. Clayton, Richard D. Shih, David L. DeMets, Dennis G. Maki, Charles H. Hennekens |
| 14 |
[GO] |
2022―Feb―07 |
Status of Planned and Ongoing Paediatric Trials Investigating COVID-19 Vaccines: A Cross-Sectional Study of Paediatric Clinical Trials Planned in Agreed PIPs and/or Registered in Clinical Trial Databases |
Helle Christiansen, Steffen Thirstrup, Christine Erikstrup Hallgreen |
| 15 |
[GO] |
2022―Feb―07 |
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences? |
Kevin Klein, Pieter Stolk, Pär Tellner, Virginia Acha, Sarah Montagne, Isabelle Stöckert |
| 16 |
[GO] |
2021―Mai―13 |
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic |
Yongming Qu, Ilya Lipkovich |
| 17 |
[GO] |
2021―Mai―03 |
The Role of Regulatory Sciences from the Perspective of the Cuban Medicines Regulatory Agency: The Impact of COVID-19 in Promoting Innovation, Cooperation and Scientific Thinking |
Belkis Romeu, Yaquelín Rodríguez, Silvia Bendiner |
| 18 |
[GO] |
2021―Apr―11 |
Measuring Progress of Regulatory Convergence and Cooperation Among Asia-Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic |
Sannie Siaw Foong Chong, Mirinea Kim, Michelle Limoli, Eric Obscherning, Patricia Wu, Lila Feisee, et al. (+2) Nobumasa Nakashima, John C. W. Lim |
| 19 |
[GO] |
2021―Mrz―22 |
Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 |
Timothé Ménard |
| 20 |
[GO] |
2020―Dez―26 |
Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer is Not Yet! A Time Series (Forecasting) Study |
Iraj Daizadeh |
| 21 |
[GO] |
2020―Dez―24 |
Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further |
Névine Zariffa, Jonas Haggstrom, Frank Rockhold |
| 22 |
[GO] |
2020―Nov―25 |
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 |
Max Wegner |
| 23 |
[GO] |
2020―Nov―05 |
Correction to: Patient Contribution to the Development and Safe Use of Medicines During the Covid-19 Pandemic |
Peter J. Pitts, François Houÿez |
| 24 |
[GO] |
2020―Okt―27 |
Patient Contribution to the Development and Safe Use of Medicines During the Covid-19 Pandemic |
Peter J. Pitts, François Houÿez |
| 25 |
[GO] |
2020―Okt―01 |
Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters |
Katrina A. Bramstedt |
| 26 |
[GO] |
2020―Aug―24 |
Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis |
Weichung J. Shih, Chen Yao, Tai Xie |
| 27 |
[GO] |
2020―Aug―24 |
Coronavirus Disease 2019 (COVID-19) Spread and Pharmacovigilance Implications: Expert Opinion |
Peter Yamoah, Thelma Mpoku Alalbila, Varsha Bangalee, Frasia Oosthuizen |
| 28 |
[GO] |
2020―Jun―24 |
Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic |
Shein-Chung Chow, Wei Zhang |
| 29 |
[GO] |
2020―Jun―17 |
New FDA Guidance on General Clinical Trial Conduct in the Era of COVID-19 |
J. Rick Turner |
