FDA Legal Services During Research & Development

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

RESEARCH & DEVELOPMENT SERVICES -– 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 Agreements – FDA Issues Presented By:
♦ Co-Development Agreements (e.g., future marketing
    partners)
♦ 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 regulatory
       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
Emerging FDA Issues & Their Impact on Development Plans
♦ Comment preparation on FDA initiatives
♦ Legislative responses
♦ Client-generated strategic initiatives
State Law Issues
♦ Privacy
♦ Medical Records

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