Drugs

• Comparing the NDA, 505(b)(2) and ANDA (Abbreviated New Drug Application) drug approval routes
• ANDA filing: what does the FDA require?
• Showing bioequivalence in an ANDA
• ANDA Paragraph IV Certification, and response to Notice Letters
• The role of the Orange Book in the drug approval process: what is it, why is it Orange, and why is it important?
• Regulatory Exclusivity (FDA)
  • Categories of regulatory (data) exclusivity—NCE (new chemical entity); new indication; NDF (new dosage formulation);
    ODE (orphan drug exclusivity); PED (pediatric exclusivity)’ New antibiotic exclusivity
  • overview of Hatch-Waxman and reforms under MMA
  • the role of Orange Book under Hatch-Waxman vis-à-vis the MMA
    • 30-month stay
    • patent extensions
    • ANDA-filer exclusivity (180 day)

Biologics

• Identifying products approved/regulated as biologics
• Overview of biosimilar (FOB) legislation and regulations
• The rationale for safety and efficacy concerns surrounding second generation biologics

Exclusivity for Combination Products

• Exploring exclusivities for combination products comprised of two new Orange Book listed drugs, two old drugs, a new and an old, a listed drug and device, and a listed drug and biological product