Services -- Rx Drugs & Therapeutic Biologics

Brand-Generic Competition Issues

   ♦ Non-patent product line extension       

       • strategies to change innovator products       

       • 505(b)(2) applications – major changes to approved products    

  ♦ Legal challenges to generic entry        

       • the listed drug        

       • legitimate scientific issues on equivalence        

       • Hatch-Waxman market exclusivity eligibility 

  ♦ Direct challenges to generic “equivalence”      

  ♦ ANDA Suitability Petitions – easing the regulatory burden 

  ♦ Generic drug approval counseling


Investigational New Drug (IND) Submissions

  ♦ Pre-IND meetings

        • preparation

        • submissions

   ♦ INDs

        • initial filing

        • maintenance during life of the IND – changes

        • Clinical Trial Protocol Reviews

        • Informed Consent Reviews 


New Drug Applications (NDAs), Biologics Licensing Applications (BLAs), 

and Abbreviated NDAs (ANDAs) 

   ♦ Counseling on requirements

   ♦ PDUFA and Application Fees

   ♦ Strategies to maximize approval process

   ♦ Responding to FDA Complete Response &  Refuse-to-File letters

   ♦ Achieving binding agreements with FDA on  clinical design 

   ♦ Orphan Drug Designation & Development


FDA Liaison & Meetings

   ♦ End-of-Phase meetings (I, II, III)     

   ♦ Advisory Committee preparation and meetings 


Emerging FDA Issues & Their Impact on Development Plans

   ♦ Comment preparation on FDA initiatives

   ♦ Legislative responses

   ♦ Client-generated strategic initiatives 


Post-Marketing Issues

   ♦ Changes to Approved Products

        • Regulatory Requirements counseling

            ○ Supplements

            ○ Annual Reports

        • Implementation Tactics 

   ♦ Adverse Event Handling

        • Regulatory classification of event

        • Implementing

           ○ SOPs

           ○ Filings

        • Managing Related Products Liability Risks 

To see presentations and articles on FDA regulation of Rx Drugs and Therapeutic Biologics, ...