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Therapeutic Innovation & Regulatory Science|May 2, 2018
FDA Expectations for Demonstrating InterchangeabilityKamali ChanceTherapeutic Innovation & Regulatory Science|May 2, 2018
The Safety Explorer Suite: Interactive Safety Monitoring for Clinical TrialsJeremy Wildfire, Ryan Bailey, Rebecca Z Krouse, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
Research Misconduct in FDA-Regulated Clinical Trials: A Cross-sectional Analysis of Warning Letters and Disqualification ProceedingsCraig A Garmendia, Neera Bhansali, Purnima MadhivananTherapeutic Innovation & Regulatory Science|May 2, 2018
Anticancer Drug Prescription Patterns in Japan: Future Directions in Cancer TherapyShoyo Shibata, Maiko Matsushita, Yoshimasa Saito, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
What Drives Adoption of National Labels as Global Reference Labels? A Case Study With the JPIShimon Yoshida, Rie Matsui, Chikara KikuchiTherapeutic Innovation & Regulatory Science|May 2, 2018
The Use of Real-World Evidence and Data in Clinical Research and Postapproval Safety StudiesMary Jo Lamberti, Wayne Kubick, Josephine Awatin, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
CRISPR-Cas9: A Precise Approach to Genome EngineeringJorge E Simón, Ángel S Rodríguez, Nelson Santiago VispoTherapeutic Innovation & Regulatory Science|May 2, 2018
The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and SponsorsJodi Smith-Gick, Nicola Barnes, Rocco Barone, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
Ethical Issues in Research Involving Participants With Opioid Use DisorderEmily Anderson, Lindsay McNairTherapeutic Innovation & Regulatory Science|May 2, 2018
Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-PacificJohn C W LimPageof 165