Who Said It Better? A Test of Wording Differences in the MedWatch “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements-Reference-Cited by-同舟云学术

Who Said It Better? A Test of Wording Differences in the MedWatch “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements

Published:2016-03 Issue:2 Volume:50 Page:169-173
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Aikin Kathryn J.,O’Donoghue Amie C.,Sullivan Helen W.,Betts Kevin R.,Squire Claudia

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/10.1177/2168479015596023.pdf

Reference6 articles.

1. Code of Federal Regulations (2014a), 21 CFR 310.305 (drugs); 21 CFR 600.80 (biologics); 21 CFR 803 (devices).

2. Best Pharmaceuticals for Children Act, Public Law 107–109. January 4, 2002.

3. Food and Drug Administration. Toll-free number for reporting adverse events on labeling for human drug products: Labeling Comprehension Study. 72 FR, 5056–5057. http://www.regulations.gov/#!documentDetail;D=FDA-2003-N-0313-0009. 2007. Accessed May 7, 2015.

4. Food and Drug Administration. Toll-free number for reporting adverse events on labeling for human drug products: Final Rule. 73 FR 209, 63886–63987. 2008.

5. Food and Drug Administration. Food and Drug Administration Amendments Act of 2007. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/foodanddrugadministrationamendmentsactof2007/default.htm. Accessed July 17, 2015.

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