Health Canada testing of “Jian Pai Natural Skin Care Cream,” also called ‘’Yikangshuang,” found that it contains two antifungal drugs (fluconazole and miconazole) that are not listed on the product label, and may pose serious health risks.
Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE
FDA - U.S. Food and Drug Administration
The TGA is seeking comments on the proposed RASML statements for OTC medicines containing miconazole or fluconazole. Closing date: 21 June 2018
Therapeutic Goods Administration - Australia