FDA 505b2 Pathway

FDA 505(b)(2)

The FDA 505(b)(2) pathway is an accelerated pathway to get a New Drug Approval using data that was already previously submitted by other drug companies. It was designed to help you avoid unnecessary duplication of studies which have already been performed on a previously approved drug.

This idea can be used when you are:

  • Repurposing a previously approved drug with a new indication
  • Changing the formulation of an existing drug which has superiority over the original drug (e.g. creating a slow release version of a previously approved drug)
  • Creating a combination drug where one or two previously approved ingredients have been combined

You perform a bridging study to show bioequivalence to the approved drug asset and therefore can use their safety, non-clinical data and any other relevant data.

The time saving can be years – normal NDAs take 7-10 years whereas FDA 505(b)(2) can be under 2 years. The faster pathway to approval also creates cost saving efficiencies for you.

  • Decide Therapeutic Area For Research (Review Patent Opportunity)
  • Select Cannabinoid Profile Via Expert Opinion
  • Novel Formulation Of Your Cannabinoid (IP Opportunity)
  • Pre-IND Meeting With The FDA
  • Toxicology
  • Lodge IND With FDA And Apply For Accelerator Vouchers (If Applicable)
  • Bridging Study
  • Clinical Efficacy Trials
  • Create Clinical Trial Dossier
  • Lodge For NDA