FDA approval is a lengthy and involved process with therapeutic drugs that startups must go through.

Here’s a list of the key steps to achieve FDA approval:

After basic research, the founder applies for an Investigational New Drug Application called an IND.

The founder takes the proposed therapeutic or drug through four phases of clinical trials.

Phase 1 is for safety testing. 

Phase 2 is for effectiveness.

Phase 3 focuses on additional safety testing to determine side effects.

Phase 4 focuses on additional efficacy tests.

After testing comes the New Drug Application or NDA.

The FDA reviews the NDA, including the clinical data and research, to determine approval.

There are fast-track paths for drugs that treat serious medical conditions that have no current solution.

There is also a breakthrough therapy path for drugs that show substantial improvement over the current solution.

For investing in therapeutic startups, consider the FDA pathway for the drug and where it currently resides on that pathway.

 

Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding.

Let’s go startup something today.
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Thank you for joining your host Hall T. Martin with the Startup Funding Espresso — your daily shot of startup funding and investing.
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Hall T Martin is the director of Investor Connect, which is a 501(c)(3) nonprofit dedicated to the education of investors for early-stage funding. All opinions expressed by Hall and podcast guests are solely their own opinions and do not reflect the opinion of Investor Connect. This podcast is for informational purposes only and should not be relied upon for the basis of investment decisions.