We investigate major factors that influence the potential clinical evidence required and the likelihood of a product’s acceptance in the market. Having established a working draft of our labeled indication(s), we look at the therapeutic category. What drugs have been used, are currently used and what drugs are being studied for eventual marketing?
This comparative review serves [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, November 5th, 2007.
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Foreign Inspections by FDA
Published November 5th, 2007 in News Commentary. 0 CommentsThe US General Accounting Office (GAO) criticised what it concluded is a lack of FDA inspection of foreign API and finished dosage form manufacturers. This has received a lot of coverage in the lay and professional press, especially since a huge increase in API’s is coming from China; FDA has only 13 inspections scheduled in China, a country [...]