FDA Boot Camp, American Conference Institute

September 20, 2012 to September 21, 2012
02:00 PM - 04:00 PM

FDA and healthcare partner and co-chair of firm-wide Life Sciences and Healthcare initiative, Stephen Paul Mahinka will present on biosimilars topic at the ACI's workshop "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics" during FDA Boot Camp.

View the presentation >>

Topics to be discussed include:


  • Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
  • ANDA filing: what does FDA require?
  • Showing bioequivalence in an ANDA
  • ANDA Paragraph IV Certifi cation, and response to Notice Letters
  • The role of the Orange Book in the drug approval process: what is it and why is it Orange?
  • Regulatory exclusivity (FDA)
  • NCE (new chemical entity)
  • Indication (new indication or use)
  • NDF (new dosage formulation)
  • ODE (orphan drug exclusivity)
  • PED (pediatric exclusivity)
  • Overview of Hatch-Waxman and reforms under MMA
  • The role of Orange Book under Hatch-Waxman vis-à-vis the MMA
  • Identifying products approved/regulated as biologics
  • Overview of biosimilar (FOB) legislation and regulations
  • The rationale for safety and efficacy concerns surrounding second generation biologics

Friday, September 21, 2012
2-4 pm ET

Omni Parker House, Boston
60 School Street
Boston MA, 02108