“Assessment of Pressor Effects of Drugs”—A New US FDA Draft Guidance for Industry J. Rick Turner Editorials 30 December 2018 Pages: 397 - 399
Advancing Drug Safety Through Prospective Pharmacovigilance Peter J. PittsHervé Le Louet Editorials 30 December 2018 Pages: 400 - 402
A Proposal to Replace “SRL” as the Common Term for Medical Information Response Documents Dominick AlbanoSviatlana Ferri Letters to the Editor 30 December 2018 Pages: 403 - 404
Response to “Use of Qualitative Data to Support Content Validity of Performance-Based Cognitive Outcome Assessments” Michael T. RopackiKristin HannesdottirCritical Path Institute’s Coalition Against Major Diseases and Patient-Reported Outcome Consortium Cognition Working Group Letters to the Editor 30 December 2018 Pages: 405 - 406
Sample Size Determination for a 3-Treatment 3-Period Crossover Trial in Frequency Data Kung-Jong Lui Biostatistics: Statistics 30 December 2018 Pages: 407 - 415
Strategic and Statistical Considerations on the QT Assessment of Volasertib Gudrun WallensteinBeate WalterTillmann Taube Biostatistics: Statistics Open access 30 December 2018 Pages: 416 - 422
Comparison of Dissolution Profiles: A Statistician’s Perspective Thomas Hoffelder Biostatistics: Commentary 30 December 2018 Pages: 423 - 429
A Comparative Safety Profile Assessment of Oncolytic Virus Therapy Based on Clinical Trials Takuma MatsudaHiroyo KarubeAtsushi Aruga Drug Safety: Original Article 30 December 2018 Pages: 430 - 437
Regional Differences During the ICH Regulatory Consultation Process Between the EU, US, and Japan Aimad TorquiAlina Mihaela Macau Global Perspectives: Original Article 30 December 2018 Pages: 438 - 441
Optimal Anti-cancer Drug Profiles for Effective Penetration of the Anti-cancer Drug Market by Generic Drugs in Japan Shoyo ShibataMaiko MatsushitaTakeshi Suzuki Global Perspectives: Original Article 30 December 2018 Pages: 442 - 448
The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System Andrea KeyterJoey GouwsStuart Walker Global Perspectives: Original Article Open access 30 December 2018 Pages: 449 - 458
Reports to Independent Data Monitoring Committees: An Appeal for Clarity, Completeness, and Comprehensibility Kevin A. BuhrMatthew DownsJanet Wittes Medical Communications: Original Article 30 December 2018 Pages: 459 - 468
Insights and Best Practices for Planning and Implementing Patient Advisory Boards Annick AndersonKenneth A. Getz Patient Engagement: Original Article 30 December 2018 Pages: 469 - 473
Value of Developing Plain Language Summaries of Scientific and Clinical Articles: A Survey of Patients and Physicians Daphnee S. PushparajahElizabeth ManningCatherine Arnaudeau-Bégard Patient Engagement: Original Article 30 December 2018 Pages: 474 - 481
Direct-to-Consumer Genetic Testing: Finding a Clear Path Forward Brendan Seward Policy: Review Article 30 December 2018 Pages: 482 - 488
Factors That Facilitate Regulatory Approval for Drug-Device Combination Products in the European Union and United States of America: A Mixed Method Study of Industry Views Fiona Masterson Regulatory Science: Original Article 30 December 2018 Pages: 489 - 498
Use Effectiveness of Medical Devices: A Case Study on the Deployment of Ultrasonographic Devices Martin AugustýnekDaniel LaryšKamil Kuča Regulatory Science: Original Article 30 December 2018 Pages: 499 - 506
Effective Partnering in Conducting Benefit-Risk Patient Preference Studies: Perspectives From a Patient Advocacy Organization, a Pharmaceutical Company, and Academic Stated-Preference Researchers Anne M. WolkaAngelyn O. FairchildRebecca Noel Regulatory Science: Original Article 30 December 2018 Pages: 507 - 513
Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies Alberto GrignoloZhang Mingping Special Populations: Analytical Report 30 December 2018 Pages: 514 - 522
