Umbrella Branding Is ‘Particular Concern’ As FDA Requests Research Proposals
This article was originally published in The Tan Sheet
Executive Summary
FDA seeks research proposals to evaluate consumers’ understanding of OTC drugs bearing umbrella brand names. The agency says the data also will benefit regulatory action and future guidance development as well as provide knowledge to scientists studying risk communication of drugs.
You may also be interested in...
OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA
The trade group recommends FDA write a separate proprietary name guidance for OTC drugs. FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on labeling, CHPA says in comments.
Draft Guidance On Developing Drug Names Calls For Simulation Studies
FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”
Colgate Expects ‘Volatile’ Short Term In Emerging Markets Before ‘Prosperity’ In Longer Term
“If you take a three- to five-year horizon, after a period of slowdown potentially, logically, we should expect another economic cycle that there will be more growth and prosperity," says Panagiotis Tsourapas, Colgate group president for Latin America, Asia-Pacific and Africa/Eurasia.