| 1 |
[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 |
| 2 |
[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 |
| 3 |
[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 |
| 4 |
[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 |
| 5 |
[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 |
| 6 |
[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 |
| 7 |
[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, Yurina Saito, Yuki Shimizu, Shuichi Kawarasaki, Mari Kihara, Natsumi Kinoshita, Hikari Umeda, Tatsuya Noda, Tomoaki Imamura, Yuichi Nishioka, Toshihiro Yamaguchi, Shuichiro Hayashi, Toyotaka Iguchi |
| 8 |
[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 |
| 9 |
[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 |
| 10 |
[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, Lisa M. Clayton, Richard D. Shih, David L. DeMets, Dennis G. Maki, Charles H. Hennekens |
| 11 |
[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 |
| 12 |
[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 |
| 13 |
[GO] |
2021―Mai―13 |
Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic |
Yongming Qu, Ilya Lipkovich |
| 14 |
[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 |
| 15 |
[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, Nobumasa Nakashima, John C. W. Lim |
| 16 |
[GO] |
2021―Mrz―22 |
Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 |
Timothé Ménard |
| 17 |
[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 |
| 18 |
[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 |
| 19 |
[GO] |
2020―Nov―25 |
New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 |
Max Wegner |
| 20 |
[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 |
| 21 |
[GO] |
2020―Okt―27 |
Patient Contribution to the Development and Safe Use of Medicines During the Covid-19 Pandemic |
Peter J. Pitts, François Houÿez |
| 22 |
[GO] |
2020―Okt―01 |
Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters |
Katrina A. Bramstedt |
| 23 |
[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 |
| 24 |
[GO] |
2020―Aug―24 |
Coronavirus Disease 2019 (COVID-19) Spread and Pharmacovigilance Implications: Expert Opinion |
Peter Yamoah, Thelma Mpoku Alalbila, Varsha Bangalee, Frasia Oosthuizen |
| 25 |
[GO] |
2020―Jun―24 |
Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic |
Shein-Chung Chow, Wei Zhang |
| 26 |
[GO] |
2020―Jun―17 |
New FDA Guidance on General Clinical Trial Conduct in the Era of COVID-19 |
J. Rick Turner |
