RESEARCH & DEVELOPMENT -– The Pre-Approval Phases
Clinical Trial and Other Sourcing Agreements
    ♦ CROs
    • Sponsor Master Services Agreements
    • Clinical trials management
    ♦ Investigators
    ♦ Contract Labs
    • Preclinical testing
    ♦ IRBs
    ♦ Active Pharmaceutical Ingredient (API) supply sourcing
    ♦ Component sourcing deals
    ♦ Medical advisory boards
    • structure
    • function
    ♦ Consultants
Commercial AgreementsFDA Issues Presented By:
    ♦ Co-Development Agreements
    ♦ Acquisitions involving pipeline products
    ♦ Clinical data ownership
Good Clinical Practice (“GCP”) Compliance & Training
    ♦ SOPs –
    • drafting
    • review
    ♦ Compliance
    • audits
    • training
    ♦ HIPAA and privacy considerations
    • implementing procedures in clinical trials
    • consents
    ♦ State regulatory requirements
Clinical Trial Protocol Reviews
Informed Consent Reviews
Financial Disclosure Requirements – Compliance and Strategies
    ♦ Federal:  FDA & HHS
    ♦ Institutional (e.g., university, hospital)
    ♦ Clinical trial design to minimize conflicts
Investigational New Drug (IND) and Device (IDE) Submissions
    ♦ Pre-IND and IDE meetings
    • preparation
    • submissions
    ♦ INDs & IDEs
    • initial filing
    • maintenance during life of the IND – changes
    ♦ PDUFA, MDUFMA and Application Fees
    ♦ Device Reclassification Petitions – easing the burden
    • “De Novo” petitions for truly “new” technologies
    • Traditional for pre-’76 devices
New Drug Applications (NDAs), Biologics License Applications
(BLAs), Abbreviated NDAs (ANDAs), Device Pre-Market
Approval (PMAs) Applications and Pre-Market Notification
Submissions (510k’s)                                                                       
    ♦ Counseling on requirements
    ♦ 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
    ♦ Reviews
    ♦ Training
    ♦ Audits
Emerging FDA Issues & Their Impact on Development Plans
    ♦ Comment preparation on FDA initiatives
    ♦ Legislative responses
    ♦ Client-generated strategic initiatives
State Law Issues
    ♦ Medical Records
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© 2014  Michael A. Swit.  


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