The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study
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[1] M. Sculpher,et al. Antimicrobial Resistance: Is Health Technology Assessment Part of the Solution or Part of the Problem? , 2021, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.
[2] M. Cavaleri,et al. Achieving Regulatory Alignment for Anti-Infective Clinical Trials. , 2020, ACS Infectious Diseases.
[3] R. Banzi,et al. Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval , 2019, British Journal of Clinical Pharmacology.
[4] H. Leufkens,et al. Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions. , 2019, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.
[5] M. Neri,et al. HTA and Payment Mechanisms for New Drugs to Tackle AMR , 2019 .
[6] Richard Veselý,et al. A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why , 2019, Clinical pharmacology and therapeutics.
[7] A. Trett,et al. How Should the Value Attributes of Novel Antibiotics Be Considered in Reimbursement Decision Making? , 2019, MDM policy & practice.
[8] L. Liberti,et al. The Confluence of Accelerated Regulatory and Health Technology Assessment Access Pathways , 2019, Clinical pharmacology and therapeutics.
[9] R. Banzi,et al. FDA vs EMA: review times and clinical evidence on novel drugs at the time of approval. , 2019, British journal of clinical pharmacology.
[10] E. Klein,et al. Introduction and geographic availability of new antibiotics approved between 1999 and 2014 , 2018, PloS one.
[11] Elias Mossialos,et al. What are the economic barriers of antibiotic R&D and how can we overcome them? , 2018, Expert opinion on drug discovery.
[12] N. Rawson. Canadian, European and United States new drug approval times now relatively similar , 2018, Regulatory toxicology and pharmacology : RTP.
[13] J. Wallach,et al. The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements , 2018, Clinical trials.
[14] M. Ouellette,et al. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. , 2017, The Lancet. Infectious diseases.
[15] Y. Carmeli,et al. Revitalizing the antibiotic pipeline: Stimulating innovation while driving sustainable use and global access , 2018 .
[16] U. Theuretzbacher. Antibiotic innovation for future public health needs. , 2017, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases.
[17] P. Moja,et al. Antibacterial agents in clinical development: an analysis of the antibacterial clinical development pipeline, including tuberculosis , 2017 .
[18] A. Haycox,et al. Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation , 2017, Frontiers in Pharmacology.
[19] R. Ebright,et al. White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs , 2017, The Journal of infectious diseases.
[20] Aris Angelis,et al. Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries , 2017, The European Journal of Health Economics.
[21] Z. Babar,et al. How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries , 2017, Applied Health Economics and Health Policy.
[22] H. Boucher,et al. Past, Present, and Future of Antibacterial Economics: Increasing Bacterial Resistance, Limited Antibiotic Pipeline, and Societal Implications , 2017, Pharmacotherapy.
[23] A. Kesselheim,et al. Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals. , 2016, Bioorganic & medicinal chemistry.
[24] E. Nicod. Why do health technology assessment coverage recommendations for the same drugs differ across settings? Applying a mixed methods framework to systematically compare orphan drug decisions in four European countries , 2016, The European Journal of Health Economics.
[25] J. Altman,et al. Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006–2015: a cohort study , 2016, European Journal of Clinical Pharmacology.
[26] L. Liberti,et al. An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency , 2016, Therapeutic innovation & regulatory science.
[27] J. O'Neill,et al. Tackling drug-resistant infections globally: final report and recommendations , 2016 .
[28] Elias Mossialos,et al. A systematic review and critical assessment of incentive strategies for discovery and development of novel antibiotics , 2015, The Journal of Antibiotics.
[29] Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products , 2016 .
[30] Lawrence R. Ness,et al. Are We There Yet - Data Saturation in Qualitative Research (TQR Published).pdf , 2015 .
[31] T. Eguale,et al. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? , 2015, Pharmacoepidemiology and drug safety.
[32] E. Cox,et al. Antibacterial Drug Development: Challenges, Recent Developments, and Future Considerations , 2014, Clinical pharmacology and therapeutics.
[33] A. Culyer. International Network of Agencies for Health Technology Assessment , 2014 .
[34] Establishing a list of qualifying pathogens under the Food and Drug Administration Safety and Innovation Act. Final rule. , 2014, Federal register.
[36] Harlan M. Krumholz,et al. Regulatory review of novel therapeutics--comparison of three regulatory agencies. , 2012, The New England journal of medicine.
[37] Robert K. Yin,et al. Qualitative Research from Start to Finish , 2010 .
[38] Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections , 2010 .
[39] Pat Bazeley,et al. Analysing Qualitative Data: More Than 'Identifying Themes' , 2009 .
[40] P. Sainsbury,et al. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. , 2007, International journal for quality in health care : journal of the International Society for Quality in Health Care.
[41] S. Walker,et al. A Comparison of the Drug Review Process at Five International Regulatory Agencies , 2007 .
[42] V. Braun,et al. Using thematic analysis in psychology , 2006 .
[43] R. Busse,et al. Methods for the comparative evaluation of pharmaceuticals , 2005, GMS health technology assessment.
[44] C. Cassell,et al. Essential guide to qualitative methods in organizational research , 2004 .
[45] Hilde van der Togt,et al. Publisher's Note , 2003, J. Netw. Comput. Appl..
[46] N. Rawson. Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998. , 2000, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.