Drug name review
FDA drug name review should be based on data collected from sponsors, rather than from internal agency tests, HHS Advisory Committee on Regulatory Reform recommends during Sept. 9 teleconference. FDA is developing three guidances to help avoid medication errors caused by drug name confusion: to define policy on submitting trade names; provide labeling recommendations; and provide specifics on analysis and submission of data for review (1"The Pink Sheet" Sept. 10, 2001, p. 32)...
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Drug and biologic sponsors should conduct a risk assessment on the product's name, labeling and packaging to minimize medication errors, an FDA concept paper states
FDA is working on three guidances to help avoid medication errors due to drug name confusion. The first addresses policy considerations related to the process of submitting trade names, such as what FDA will and will not accept; another guidance provides general recommendations on labeling and packaging issues, including prominence and total drug content; the third will provide more specifics on the analysis and submission of data for trade name review, including possible studies companies could conduct to evaluate look-alike and sound-alike names
The developers of eleven new drugs could learn this week whether the European Medicines Agency will set them on course for pan-EU marketing approval.