#342: Planning an FDA Submission

The FDA is actively shaping the regulatory landscape for Artificial Intelligence (AI) and Machine Learning (ML) in real time. As the agency expands its internal expertise through the Digital Health Center of Excellence, FDA reviewers are becoming highly sophisticated. The era of ...  Show more

The MedTech industry widely misread the FDA's recent warning letter to Purolea Cosmetics Lab as a direct crackdown on Artificial Intelligence (AI). Host Etienne Nichols challenges this narrative, explaining that viewing the event strictly through an AI lens causes medical device ...  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 ...