New Horizons in Pediatric Drug Development Stephen P. SpielbergRonald Portman Editorial 30 December 2015 Pages: 613 - 614
Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline Ann Meeker-O’ConnellMaria Magdalena BordaLeslie M. Sam Sponsored Special Section by TransCelerate BioPharma: Analytical Report Open access 30 December 2015 Pages: 615 - 622
Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28–29, 2014 Martin OffringaJonathan M. DavisRobert M. Nelson Special Section on Pediatrics: Analytical Report 30 December 2015 Pages: 623 - 631
Attention-Deficit Hyperactivity Disorder and Pharmacotherapy—Past, Present, and Future: A Review of the Changing Landscape of Drug Therapy J. J. ConnollyJ. T. GlessnerH. Hakonarson Special Section on Pediatrics: Review 30 December 2015 Pages: 632 - 642
Advancing Pediatric Psychiatry Research: Linking Neurobiological Processes to Novel Treatment and Diagnosis Through the Research Domain Criteria (RDoC) Project Stacy DruryBruce Cuthbert Special Section on Pediatrics: Review 30 December 2015 Pages: 643 - 646
Best Practice Recommendations Regarding the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients Charles ThompsonDon LombardiLiza Squires Special Section on Pediatrics: Analytical Report 30 December 2015 Pages: 647 - 658
Regulatory and Funding Strategies to Develop a Safety Study of an Auditory Brainstem Implant in Young Children Who Are Deaf Laurel M. FisherLaurie S. EisenbergLos Angeles Pediatric ABI Team Special Section on Pediatrics: Original Research 30 December 2015 Pages: 659 - 665
Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients Edward Tabor Special Section on Pediatrics: Analytical Report 30 December 2015 Pages: 666 - 672
iCAN: Providing a Voice for Children and Families in Pediatric Research Hadleigh ThompsonNicholas FredericoCharles Thompson Special Section on Pediatrics: Review 30 December 2015 Pages: 673 - 679
Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014 Frank J. SasinowskiErika B. PanicoJames E. Valentine Regulatory Science: Original Research 30 December 2015 Pages: 680 - 697
An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees Jonathan Seltzer Regulatory Science: Original Research 30 December 2015 Pages: 698 - 705
Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins Stella StergiopoulosCarrie A. BrownKenneth A. Getz Product Safety: Original Research 30 December 2015 Pages: 706 - 716
Topic of Timely Interest—Decision Criteria for Negative QT Assessment Using Exposure Response Analysis of Data From Early-Phase Clinical Studies: Letter to the Editor Borje DarpoGeorg FerberNorman Stockbridge Product Safety: Letter to the Editor Open access 30 December 2015 Pages: 717 - 719
A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan Scott BrandDiana BartlettKristin Neff Product Development and Innovation: Original Research 30 December 2015 Pages: 720 - 729
Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and Ratings Cesar MedinaFrances J. Richmond Product Development and Innovation: Analytical Report 30 December 2015 Pages: 730 - 738
Bowel Preparations for Colonoscopy: A Regulatory Perspective Klaus GottliebJ. Rick TurnerFez Hussain Product Development and Innovation: Analytical Report 30 December 2015 Pages: 739 - 744
Establishing Return-on-Investment Expectations for Patient-Centric Initiatives Kenneth A. Getz Product Development and Innovation: Analytical Report 30 December 2015 Pages: 745 - 749
Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia Shruti RastogiM. KalaivaniG. N. Singh Global Perspectives: Review 30 December 2015 Pages: 750 - 755
Evaluation of an Adaptive Maximizing Design Study Based on Clinical Utility Versus Morphine for TRV130 Proof-of-Concept and Dose-Regimen Finding in Patients With Postoperative Pain After Bunionectomy James A. BologneseRuth Ann SubachFranck Skobieranda Biostatistics: Original Research 30 December 2015 Pages: 756 - 766