FDA Law Blog
OCTOBER 16, 2023
Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Lloyd Minor, Dean of the Stanford University School of Medicine discusses both the potential promise of increasing use of AI in healthcare settings (e.g.,
pharmaphorum
SEPTEMBER 8, 2022
The Digital Medicine Society (DiME) is today releasing a new set of open-access resources to advance the use of nocturnal scratch in the treatment of atopic dermatitis (AD). .
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
OCTOBER 14, 2021
Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.
pharmaphorum
DECEMBER 11, 2022
It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. AI gets us closer to personalised medicine.”. In 2019, he was awarded “Excellence in Medical Affairs Award” by the Association of Pharmaceutical Medicine Singapore (APMS).
The Pharma Data
NOVEMBER 12, 2021
director of the FDA’s Center for Devices and Radiological Health. “We An FDA investigator’s list of examination compliances doesn’t constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its enforcing regulations. Source link: [link].
Drug Discovery World
APRIL 14, 2023
Carl H June, MD, FAACR – Lifetime Achievement in Cancer Research June, a Fellow of the AACR Academy, is the Richard W Vague Professor in Immunotherapy, Director of the Center for Cellular Immunotherapies, and Director of the Parker Institute for Cancer Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania.
The Pharma Data
NOVEMBER 6, 2020
director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a disorder that develops in some people who have experienced a shocking, scary, or dangerous event. The FDA granted the marketing authorization to Nightware, Inc.
Expert insights. Personalized for you.
119 
Let's personalize your content