FDA Legal Services Relating to Drugs and Therapeutic Biologics

FDACounsel.com -- Legal Services -- for the life of a Life Sciences company

DRUGS & THERAPEUTIC BIOLOGICS SERVICES

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 deficiency letters
   ♦ Achieving binding agreements with FDA on
       clinical design
FDA Liaison & Meetings
   ♦ End-of-Phase meetings (I, II, III)
   ♦ Advisory Committee preparation and meetings
Promotion and Advertising During R&D & Pending Approval
   ♦ Reviews
   ♦ Training

Brand-Generic Competition Issues
   ♦ Non-patent product line extension
       • strategies to change innovator products
       • 505(b)(2) applications – major changes to
           approved products
   ♦ Legal “Blocking” of generic entry
       • altering 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
Emerging FDA Issues & Their Impact on Development Plans
   ♦ Comment preparation on FDA initiatives
   ♦ Legislative responses
   ♦ Client-generated strategic initiatives
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

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For presentations and articles on Drug Development, just click here ...

For presentations and articles on Clinical Research, just click here ...

For presentations and articles on Generic Drug Regulation, just click here ...