2013

  • Baird et al. Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development. Ther. Inn. Reg. Sci. 2013; 47:474-483
  • De Jong et al. Appropriate evidence for adaptive marketing authorization. Nat. Rev. Drug Discov. 2013; 12:647-648
  • Forda et al. Priorities for improving drug research, development and regulation. Nat. Rev. Drug Discov. 2013; 12:247-248
  • Henshall et al. Understanding the Role and Evidence Expectations of Health Technology Assessment and Coverage/Payer Bodies: What Are They Looking for, and How and Why Does This Differ From What Regulators Require? Ther. Inn. Reg. Sci. 2013; 48:341-346
  • Tsoi et al. Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences, Expert Rev Pharmacoecon. Outcomes Res. 2013; 13:497-511
  • Wonder et al. Early scientific advice obtained simultaneously from regulators and payers: findings from a pilot study in Australia, Value in Health. 2013; 16:1067-1073

2012

  • Barker & Garner. Adaptive drug development and licensing. Regulatory Rapporteur. 2012; 9:13-14
  • Brekenridge et al. Medicines Regulation and Health Technology Assessment. Clin. Phar. Ther. 2012; 87: 152-154
  • Eichler et al. Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval. Nature. 2012; 91: 426-437
  • Frnsdal et al. Interaction initiatives between regulatory, health technology assessment and coverage bodies, and industry. Int. J. Technol. Assess. Health Care. 2012; 28:374-81.
  • Liberti et al. Preparing for regulatory review and reimbursement decisions: a case for cooperation between regulatory authorities and health technology assessment agencies. Pharm. Med. 2012; 23:263-267
  • Messner & Tunis. Current and future state of FDA-CMS parallel reviews. Clin. Pharmacol. Ther. 2012; 91:383-385