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PhRMA Seeks Repeal Of Brand Name Review Rule Until A Benefit Is Shown

Executive Summary

The pharmaceutical industry wants FDA to prove its proprietary name review program is worth the effort.

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Draft Guidance On Developing Drug Names Calls For Simulation Studies

FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals.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.”

Draft Guidance On Developing Drug Names Calls For Simulation Studies

FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals.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.”

Drug Proprietary Name Selection: Draft Guidance Calls For Simulation Studies

FDA draft guidance on developing proprietary drug names recommends series of steps for sponsors to evaluate a proposed name; safety review includes testing name with healthcare professionals.

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