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Getting Unapproved Drugs (DESI, etc.) Approved

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 getting sponsors to bring these drugs into compliance, that is, get them approved.

The latest effort is an FDA-written on-line course entitled “Bringing an unapproved drug into compliance” at its own web site.  Please note that when the Agency uses the term NDA, it can refer to either 505(b)(1) or 505(b)(2).  Generally, since the drug has been marketed, but not approved, there can be useful public information that can be used to support some aspects of the NDA requirements for approval.  Thus, the route taken for many, if not most, of these unapproved products is 505(b)(2).