Fast-tracking of new drugs: getting the balance right
- PMID: 30116074
- PMCID: PMC6091770
- DOI: 10.18773/austprescr.2018.032
Fast-tracking of new drugs: getting the balance right
Keywords: drug regulation; product approval.
Conflict of interest statement
Conflict of interest: Paul Kubler received sponsorship from Bristol-Myers Squibb to attend the 2017 EULAR Annual European Congress of Rheumatology and has acted as a consultant to Abbvie, Eli Lilly and Reckitt Benckhiser.
References
-
- Sansom L, Delaat W, Horvath J. Review of medicines and medical devices regulation: report on the regulatory framework for medicines and medical devices. Canberra: Department of Health; 2015. http://www.health.gov.au/ internet/main/publishing.nsf/content/expert-re... [cited 2018 Jul 1]
-
- Therapeutic Goods Administration. Consultation: expedited pathways for prescription medicines. Eligibility criteria and designation process. Version 1.0, Oct 2016. Canberra: Therapeutic Goods Administration; 2016. https://www.tga.gov.au/consultation/consultation-expedited-pathways-pres... [cited 2018 Jul 1]
-
- Therapeutic Goods Administration. Priority review registration process: for priority review designated prescription medicines. Version 1.1, July 2017. Canberra: Therapeutic Goods Administration; 2017. https://www.tga.gov.au/publication/priority-review-registration-process [cited 2018 Jul 1]
-
- Center for Drug Evaluation and Research. Advancing health through innovation: 2017 new drug therapy approvals. Silver Spring (MD): US Food and Drug Administration; 2018. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ DrugInnovation/ucm5... [cited 2018 Jul 1]
-
- Davis C, Naci H, Gurpinar E, Poplavska E, Pinto A, Aggarwal A. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BMJ 2017;359:j4530. 10.1136/bmj.j4530 - DOI - PMC - PubMed
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