Is your company currently marketing an unapproved DESI, Monograph or Grandfathered drug product? If so, you should be aware that the regulatory landscape has changed and FDA approvals will soon be needed. Pharmaceutical Development Group (PDG) has already established successful regulatory roadmaps and strategies for securing NDA approvals and marketing exclusivities of DESI and grandfathered drugs.

On Tuesday, January 9th, 2007 FDA held a Workshop on Marketed Unapproved Drugs and reaffirmed its commitment to tackling the unapproved drugs problem using a multi-pronged approach that includes enforcement, education, incentives, other measures.

What does this mean to you? There will be winners and losers as FDA tackles the problem of unapproved drugs. Your products may be threatened as others cash in on the opportunity to gain regulatory exclusivity of them. Conversely, unprecedented opportunity has emerged to gain exclusivity of currently multi-sourced unapproved drugs. Are you prepared to navigate the regulatory pathways that FDA has set forth to capitalize on these opportunities? Are you positioned to be one of the market winners? Click here to find out how PDG can help.