SignatureMD
AUGUST 17, 2023
One of the latest breakthroughs affecting the well-being of society may not have originated in a lab, but it could affect the health and practice of medicine as we know it. It’s an artificial intelligence (AI) chatbot known as ChatGPT. This is more than a trendy app; ChatGPT is a form of generative AI that […] The post How will AI and ChatGPT impact concierge medicine?
The Clinical Problem Solvers
AUGUST 16, 2023
[link] Episode 299: Neurology VMR – Clumsiness Episode description : We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, María presents a case of clumsiness to Andrea and Sridhara. Neurology DDx Schema Andrea Mendez Colmenares @andreamendez92 Andrea is a Venezuelan medical doctor and cognitive neuroscientist specializing in advanced white matter imaging.
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FDA Law Blog
AUGUST 16, 2023
By Douglas B. Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. He talked about regulatory discretion being exercised for drug manufacturing facilities with serious compliance problems, about how firms should respond to FDA inspectional observations, and about an upcoming guidance that will be of
GeriPal
AUGUST 17, 2023
Summary Transcript Summary It’s been over two years since one of the worst product launches of all time – Aduhelm (aducanumab). Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”.
FDA Law Blog
AUGUST 16, 2023
By Dara Katcher Levy — Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again! OPDP is back in the game, letting all the people know that they are back to run the show. In what may be the surprise “ Warning Letter of the Year ” (can you tell this blogger was pretty shocked?
FDA Law Blog
AUGUST 14, 2023
By Douglas B. Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. Jennifer Maguire, the Director of the Office of Quality Surveillance within the Office of Pharmaceutical Quality at CDER, told attendees that there were 163 FDA inspections from the beginning of October 2022 to the end of March 2023 conducted at drug manufacturing f
FDA Law Blog
AUGUST 13, 2023
By Riëtte van Laack — On August 7, 2023, a little less than five months before the registration and listing of cosmetic product facilities and products becomes mandatory, FDA announced the availability of a draft guidance regarding the new facility registration and product listing requirements under the Modernization of Cosmetic Regulations Act of 2022 (MOCRA).
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