Ep.012 S&E Podcast: FDA Regulatory Roundup: CDER Human Factors ANDA Guidance (ft. Melissa Lemke)

Mar 42 min read

Episode 012: Join us in our latest episode of Safe and Effective, where we take a deep (and possibly exasperated) dive into one of the most debated regulatory guidance in the human factors drug-device combination product generics world — the FDA’s Comparative Analyses and Comparative Use Human Factors Studies Guidance — with none other than our dear friend, industry powerhouse, and regulatory truth-teller, Melissa Lemke.

FDA Regulatory Roundup:

CDER Human Factors ANDA Guidance (ft. Melissa Lemke)

We’re tackling the big questions head-on:

What does this guidance actually say (versus what people think it says)?
Where does it hit the mark?
And where does it leave industry and regulators seemingly speaking two different languages?

From decoding the intent behind comparative use studies to unpacking why the non-inferiority statistical approach is still causing headaches for both regulatory and human factors professionals, Melissa and Heidi break down the nuances of this guidance — calling out problem areas, highlighting the biggest misconceptions, and, of course, offering a few unsolicited (but definitely necessary) ideas for improvement.

Whether you’re a regulatory pro navigating drug-device submissions, a human factors engineer caught in the crossfire of comparative studies, or just here for some unfiltered industry banter, this episode is a front-row seat to the kind of candid, behind-the-scenes conversations that don’t make it into official guidance documents.

Expect sharp insights, a bit of regulatory myth-busting, and plenty of “did they really just say that?” moments —because if we’re going to talk about FDA guidance, especially the CDER Human Factors ANDA Guidance, we’re at least going to make it worth your time.

Listen to the podcast HERE or on your favorite podcast platform.

You can also find us at safeeffectivepodcast.com, our LinkedIn page Safe and Effective | The Medical Human Factors Podcast, or our Instagram: @safeeffectivepodcast.