FDA uses the term ‘Unapproved Drugs’ to refer to any drug that is marketed in the U.S. without FDA approval. There are hundreds, maybe thousands of these drugs in the U.S.. We have written about the efforts of FDA to remove them from the market. But also FDA has devoted a lot of resources to [...]
Archive for December 22nd, 2009
Getting Unapproved Drugs (DESI, etc.) Approved
Published December 22nd, 2009 in 505(b)(2) Issues. 0 Comments505(b)(2) Approval Standards – Referenced Studies
Published December 22nd, 2009 in Uncategorized. 0 CommentsAwareness of current FDA and its Division standards is important when preparing a new submission. A basic premise for a 505(b)(2) submission to the Agency is that the application contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by [...]
