ClinicalTrials.gov: An Underutilized Source of Research Data About the Design and Conduct of Commercial Clinical Trials Harold E. GlassLucas M. GlassJeffrey J. DiFrancesco Clinical Trials 30 December 2015 Pages: 218 - 224
Investigating the Efficacy of Clinical Trial Monitoring Strategies: Design and Implementation of the Cluster Randomized START Monitoring Substudy Katherine Huppler HullsiekJonathan M. KaganINSIGHT START Monitoring Substudy Group Clinical Trials 30 December 2015 Pages: 225 - 233
A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center Yun Jung ChoiHyeJung JeonTae Won Kim Clinical Trials 30 December 2015 Pages: 234 - 238
Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products Marilyn TsourounisJeffrey StuartJoseph Barone Regulatory Science 30 December 2015 Pages: 239 - 248
General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline Yoshiaki UyamaEriko YamazakiE6 Discussion Group under the International Pharmaceutical Regulators Forum Regulatory Science 30 December 2015 Pages: 249 - 253
Breakthrough Therapy Designation: Bringing Innovation Swiftly to Patients Arpita Shah Regulatory Science 30 December 2015 Pages: 256 - 261
Implementing a Process to Review Product-Specific Misinformation in Online Drug Information Compendia Sonia R. TalwarNancy T. CrudeleJ. David Haddox Regulatory Science 30 December 2015 Pages: 262 - 268
Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis Neal E. StormFrances J. Richmond Global Perspectives 30 December 2015 Pages: 269 - 278
Actions of the National Regulatory Authorities in 10 Low- and Middle-Income Countries Following Stringent Regulatory Authority Safety Alerts on Rosiglitazone Jude NwokikeLassane KaboreAndy Stergachis Global Perspectives 30 December 2015 Pages: 279 - 283
Introducing Internet Retailing of OTC Drugs in Japan: Revision of the Pharmaceutical Affairs Law Kiyohito NakaiTaihei Tanaka Global Perspectives 30 December 2015 Pages: 284 - 288
Principled Structured Incorporation of Clinical Knowledge Into Strategic Development Decisions A. Lawrence GouldRajesh KrishnaJeffrey Saltzman Product Development and Innovation 30 December 2015 Pages: 289 - 296
The First Paediatric Use Marketing Authorisation: A Case Study John WatsonKulminder Nowacki Special Populations 30 December 2015 Pages: 297 - 301
Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral Drugs Jeremiah D. MomperYang ChangGilbert J. Burckart Special Populations 30 December 2015 Pages: 302 - 309