The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study

[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.

[35]  Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements , 2013 .

[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.