Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011

Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011–2017

Published:2021-05-10 Issue:5 Volume:55 Page:918-925
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Jones Paul R.^ORCID,Walther Elisabeth J.,Nguyen Andrew,Santiago Jonas,Pearsall Bryon M.

Publisher

Springer Science and Business Media LLC

Subject

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

Link

https://link.springer.com/content/pdf/10.1007/s43441-021-00270-3.pdf

Reference31 articles.

1. Code of Federal Regulations. 21 CFR 208: Subparts A and B, Sections 208.1–208.26. [Accessed September 21, 2018]. http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=00e07c94894b3d9263ddc3bf34d48951&mc=true&n=pt21.4.208&r=PART&ty=HTML.

2. FDA. Medication guides. [Accessed January 15, 2019]. http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm. 2018, August.

3. Ratzan SC, Parker RM. Introduction. In: CR Selden M Zorn, SC Ratzan, RM Parker, eds. National Library of Medicine Current Bibliographies in Medicine: Health Literacy. NLM Pub. No. CBM 2000–1. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services; 2000.

4. Aker J, Beck M, Papay JI, et al. Consumers better understand and prefer simplified written drug information: an evaluation of 2 novel formats versus the current CMI. Ther Innov Regul Sci. 2013;47(1):125–32.

5. FDA. Guidance: useful written consumer medication information (CMI). 2006, July. [Accessed January 15, 2019]. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080602.pdf.