#342: Planning an FDA Submission

In this episode, Etienne Nichols sits down with Staci Miller, a Human Factors and UX Strategist at GenUX, to demystify the role of human factors (HF) in the medical device regulatory pathway. Staci explains that many companies mistakenly treat HF as a "box-checking" exercise late ...  Show more

In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock" international medical device companies face when entering the U.S. market. They challenge the traditional assumption that a device should a ...  Show more

Rules for the regulation of medical devices, such as hip prostheses and implantable defibrillators, are complex and differ from those for drugs. Aaron Kesselheim, MD, JD, MPH, and Jonathan Darrow, SJD, LLM, JD, MBA, both faculty members in the Division of Pharmacoepidemiology ...

<span style= "font-size: 12pt;"><span lang="EN" style= "mso-ansi-language: EN;" xml:lang="EN">Sarah Gallo</span> <span lang="EN" style="mso-ansi-language: EN;" xml:lang="EN">is ...

It’s worse than you think. Dr. Jane Ruby, a scientist with over 20 years of experience in regulatory processes for drug approval with the FDA, explains several important ways that the FDA and the drug companies violated the most basic safety protocols at every stage of the develo ...  Show more

<span style= "color: #333333; background: white;">Tracy Fink</span> <span style="color: #333333; background: white;">is the Director of Scientific Programs and Science and Poli ...