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Therapeutic Innovation & Regulatory Science|October 23, 2023
Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug ApprovalsMuhammed Y Idris, William E Fitzsimmons, Priscilla PemuTherapeutic Innovation & Regulatory Science|October 10, 2023
Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in BrazilFlávia Nathiely Silveira Fachel, Roselena Silvestri Schuh, Patrícia Bencke Grudzinski, et al.Therapeutic Innovation & Regulatory Science|October 3, 2023
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and JapanAkira Ito, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|September 25, 2023
Training New DMC Members: A Call to ActionFrank Rockhold, Kenneth Mahaffey, David DeMetsTherapeutic Innovation & Regulatory Science|June 21, 2023
Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the QuestionWendy Manko Singer, Elizabeth MacEntee Pileggi, Yvonne Gibble, et al.Therapeutic Innovation & Regulatory Science|November 6, 2019
Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient SafetyJeremy Jokinen, Dominique Bertin, Bruce Donzanti, et al.Therapeutic Innovation & Regulatory Science|November 7, 2019
Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective StudyShray Bablani, Manthan D JanodiaTherapeutic Innovation & Regulatory Science|February 20, 2020
Analysis of the Authorized Target Populations for Fixed Dose Combination Products Between 2000 and 2017 Reveals Discrepancies Between EMA's and FDA's Views on Initial Dual-TherapyOle Jannik Bjerrum, Sascha Eichendorff, Nada Bassam AlkisTherapeutic Innovation & Regulatory Science|February 20, 2020
Probiotics and Their Quality-Related Concerns: Highlights From the Saudi Arabian MarketFahad S Aldawsari, Bandar S Bin Helel, Yahya M Al Shehry, et al.Therapeutic Innovation & Regulatory Science|February 20, 2020
A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction Among StakeholdersYunling Xu, Nelson Lu, Lilly Yue, et al.Pageof 165