Investigating Rates of Food and Drug Administration Approvals and Guidances in Drug Development: A Structural Breakpoint/Cointegration Timeseries Analysis-Reference-Cited by-同舟云学术

Investigating Rates of Food and Drug Administration Approvals and Guidances in Drug Development: A Structural Breakpoint/Cointegration Timeseries Analysis

Published:2020-01-31 Issue:5 Volume:54 Page:1056-1067
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Daizadeh Iraj^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1007/s43441-020-00123-5.pdf

Reference38 articles.

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2. Morrison C. Fresh from the Biotech Pipeline 2018. Nat Biotech. 2019;37:118–23.

3. Weintraub W. FDA promises ‘elevated’ new drug approvals but warns of potential pitfalls: report. Fierce Pharmax. https://www.fiercepharma.com/pharma/fda-promises-elevated-new-drug-approvals-but-warns-potential-pitfalls-report (2019). Accessed 10 Jul 2019.

4. Daizadeh I. Pulmonary arterial hypertension: a case study in FDA expedited program designations. Ther Innov Regul Sci. 2019;53:264–9.

5. Cai J, Wang T, McAuslane N, Liberti L. OP172 Do expedited regulatory pathways affect time to health technology assessment decision? Int J Technol Assess Health Care. 2019;34(51):63.

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