May 12, 2025

What is the FDA Drug Approval Process?

Have you ever wondered what it takes to get a new drug to market?

The FDA drug approval process is a critical pathway that ensures safety and efficacy before new treatments reach the public.

In our latest discussion, Josh Wilson speaks with Allan Shaw about the intricate steps involved, from filing an IND application to conducting thorough Phase 1, 2, and 3 trials.

Whether you're interested in the biotechnology field or just curious about the pharmaceutical industry's inner workings, this conversation sheds light on the dedication and precision required to bring new drugs to market. Don't miss out on this insightful discussion.

Tune in now! #PharmaceuticalIndustry

#FDADrugApproval #HealthcareInnovation

Disclaimer: Joshua Wilson is a registered investment banking representative and a licensed real estate broker. The content of this podcast is for informational purposes only and should not be considered legal, financial, or compliance advice. This podcast is not a substitute for professional advice. All views and opinions expressed by the host and guests are their own and do not necessarily reflect the policies or positions of any regulatory agency, organization, or employer. Listeners are encouraged to consult their own compliance teams, legal counsel, or financial advisors to ensure adherence to applicable regulations, including SEC, FINRA, and other industry-specific requirements. This podcast does not constitute a solicitation or recommendation for any financial products or services.

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Allan L Shaw Profile Photo

Allan L Shaw

CFO & Board Member

Allan L. Shaw is a highly regarded biopharma executive and board member with extensive senior global strategic, financial, M&A, operational, capital markets, and governance experience. He is a five-time public company Chief Financial Officer and has served on seven public boards, including chairing four audit committees and three compensation committees. Mr. Shaw has actively participated in the sourcing, development, and commercialization of various drug products in numerous therapeutic areas.
Mr. Shaw is currently involved with a portfolio of healthcare activities. Most recently, he took Syndax Pharmaceuticals public as its Chief Financial Officer and previously served as a Managing Director of Alvarez & Marsal, a global professional services firm, where he led their biopharmaceutical consulting practice. Mr. Shaw's previous experience includes serving as the Chief Financial Officer of Serono S.A., Portage Biotech Inc., NewLead Holdings Ltd., and Viatel, Inc.
He presently serves on the board of directors of CalciMedica Inc., Evecxia, and the Edith & Carl Marks JCH of Bensonhurst, a non-profit organization where he chairs their finance committee. Mr. Shaw has previously served on the board of directors of Blue Water Vaccines, Vivus, Inc., Akari Therapeutics, Plc., Central New York Biotech Accelerator, NewLead Holdings LTD., Navios Maritime Holdings, Inc., and Serono S.A. as an Executive Management Board Member, as well as Viatel Inc.
Mr. Shaw had a monthly column in Life Science Leader magazine entitled “Deeper Dive- A CFO insider’s view of th… Read More