Why is this Important? You have to understand what regulatory approvals you will need and how that will impact payment from payers, providers, and patients.
|Key Actions||Things to Consider||Tool Kit|
|Find professional consultants with relevant clinical & regulatory expertise||Find a consultant with domain expertise (e.g. oncology, inflammation, infectious disease, etc.)|
|Outline initial indications for use for the TPP||Expanded indications may require additional expensive and/or lengthy clinical trials to establish safety & efficacy|
|Outline regulatory requirements and action plan||Seek multiple opinions on clinical development and regulatory strategy
Consider holding a FDA pre-IND meeting to clarify pathway
|FDA Guidance Documents|
|Outline clinical trials required and timing||What evidence will be needed for FDA and European Medical Agency (EMA) approval and/or reimbursement?|
|Formulate preliminary post-approval pricing strategy||How are similar products priced and reimbursed?
Keep in mind your value proposition as it relates to pricing.
|LSWI Health Economics Consultation|