DRUGS & THERAPEUTIC BIOLOGICS
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
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
Orphan Drug Designation & Development
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
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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Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Michael A. Swit