Ali J, Califf R, Sugarman J. Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network. Account Res. 2016;23(2):79-96. PubMed: PM26192996
Basu A, Axelsen K, Grabowski DC, Meltzer DO, Polsky D, Ridley DB, et al. Real-World Data: Policy Issues Regarding their Access and Use. Med Care. 2016 Dec;54(12):1038-44. PubMed: PM27489028
Boucaud-Maitre D, Altman JJ. Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study. Eur J Clin Pharmacol. 2016 Oct;72(10):1275-81. PubMed: PM27473682
Bouvy JC, Jonsson P, Longson C, Crabb N, Garner S. Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities. Clin Pharmacol Ther. 2016 Dec;100(6):594-7. PubMed: PM27530105
Brandes A, Schwarzkopf L, Rogowski WH. USING CLAIMS DATA FOR EVIDENCE GENERATION IN MANAGED ENTRY AGREEMENTS. Int J Technol Assess Health Care. 2016 Jan;32(1-2):69-77. PubMed: PM26975757
Claxton K, Palmer S, Longworth L, Bojke L, Griffin S, Soares M, et al. A Comprehensive Algorithm for Approval of Health Technologies With, Without, or Only in Research: The Key Principles for Informing Coverage Decisions. Value Health. 2016 Sep;19(6):885-91. PubMed: PM27712718
Ermisch M, Bucsics A, Vella BP, Arickx F, Bybau A, Bochenek T, et al. Payers’ Views of the Changes Arising through the Possible Adoption of Adaptive Pathways. Front Pharmacol. 2016;7:305, 2016. PubMed: PM27733828
Faulkner SD, Lee M, Qin D, Morrell L, Xoxi E, Sammarco A, et al. Pricing and reimbursement experiences and insights in the European Union and the United States: Lessons learned to approach adaptive payer pathways. Clin Pharmacol Ther. 2016 Dec;100(6):730-42. PubMed: PM27626221
Gad M, Kriza C, Fidler A, Kolominsky-Rabas P. Accessing the medical devices market in Egypt and Saudi Arabia: a systematic review of policies and regulations. Expert Rev Med Devices. 2016 Jul;13(7):683-96. PubMed: PM27268662
Husereau D, Henshall C, Sampietro-Colom L, Thomas S. CHANGING HEALTH TECHNOLOGY ASSESSMENT PARADIGMS? Int J Technol Assess Health Care. 2016 Jan;32(4):191-9. PubMed: PM27766998
Leverkus F, Chuang-Stein C. Implementation of AMNOG: An industry perspective. Biom J. 2016 Jan;58(1):76-88. PubMed: PM26332597
Martelli N, van den BH, Borget I. New French Coverage with evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues. Value Health. 2016 Jan;19(1):17-9. PubMed: PM26797231
Martinalbo J, Bowen D, Camarero J, Chapelin M, Demolis P, Foggi P, et al. Early market access of cancer drugs in the EU. Ann Oncol. 2016 Jan;27(1):96-105. PubMed: PM26487583
McDonald L, Lambrelli D, Wasiak R, Ramagopalan SV. Real-world data in the United Kingdom: opportunities and challenges. BMC Med. 2016;14(1):97, 2016. Available from: PubMed: PM4921013
Meier A, Faulkner SD, Schoonderbeek C, Jong B, Kung J, Brindley D, et al. An assessment of implications of adaptive licensing for pharmaceutical intellectual property and regulatory exclusivity rights in the European Union. Clin Pharmacol Ther. 2016 Dec;100(6):743-53. PubMed: PM27626890
Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan. Clin Pharmacol Ther. 2016 Dec;100(6):626-32. PubMed: PM27618128 Pita R, Ehmann F, Papaluca M. Nanomedicines in the EU-Regulatory Overview. AAPS J. 2016 Nov;18(6):1576-82. PubMed: PM27527889
Rey-Ares L, Hernandez-Vasquez A, Garay OU, Pichon RA, Garcia MS, Gilardino R, et al. Medical devices: from licensing to coverage. highlights from Argentina, Brazil, Colombia and Mexico. Expert Rev Med Devices. 2016 Nov;13(11):1053-65. PubMed: PM27732123 Ruof J, Staab T, Dintsios CM, Schroter J, Schwartz FW. Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified? Health Econ Rev. 2016 Dec;6(1):46, 2016. PubMed: PM27687714 Salas-Vega S, Bertling A, Mossialos E. A comparative study of drug listing recommendations and the decision-making process in Australia, the Netherlands, Sweden, and the UK. Health Policy. 2016 Oct;120(10):1104-14. PubMed: PM27665497 Schneeweiss S, Eichler HG, Garcia-Altes A, Chinn C, Eggimann AV, Garner S, et al. Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making. Clin Pharmacol Ther. 2016 Dec;100(6):633-46. PubMed: PM27627027
Skipka G, Wieseler B, Kaiser T, Thomas S, Bender R, Windeler J, et al. Methodological approach to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs. Biom J. 2016 Jan;58(1):43-58. PubMed: PM26134089
Tafuri G, Pagnini M, Moseley J, Massari M, Petavy F, Behring A, et al. How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice. Br J Clin Pharmacol. 2016 Oct;82(4):965-73. PubMed: PM27245362
Thompson M, Henshall C, Garrison LP, Griffin AD, Coyle D, Long S, et al. Targeting improved patient outcomes using innovative product listing agreements: a survey of Canadian and international key opinion leaders. ClinicoEcon. 2016;outcomes res.. 8:427-33, 2016:-33. PubMed: PM27616892 Yue LQ, Campbell G, Lu N, Xu Y, Zuckerman B. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation. J Biopharm Stat. 2016;26(6):1136-45. PubMed: PM27540636 The U.S. FDA focuses on next-generation sequencing: Draft guidance proposals address potential standards for demonstrating analytical validity and criteria for FDA-recognized genetic variant databases. Am J Med Genet A. 2016 Oct;170(10):2496-7. PubMed: PM27643967
