FDA announced that for 2008 the full application fee for a 505(b)(2) that requires a clinical study will be $1,178,000. In addition, the establishment fee is $392,700 and the product fee is $65,030. Small businesses (defined as entities, including affiliates, with less than 500 employees) may request a waiver of the PDUFA review fee for [...]
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You are currently browsing the Drug Kennel weblog archives for the day Thursday, January 10th, 2008.
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FDA takes action against compounding pharmacies’ estriol-containing hormone products
Published January 10th, 2008 in News Commentary. 0 CommentsOn January 7, 2008, the FDA issued warning letters to several compounding pharmacies (example) advising them stop compounding hormone products contain estriol, an unapproved new drug. This activity has been going on since the mid-1990’s, popularized by the actress Suzanne Somer’s books. The general term used by this industry is bio-identical hormone replacement therapy - BHRT.
Oops, [...]