Remove 2019 Remove Manufacturing Remove Patients Remove Specialization
article thumbnail

9 Technologies That Will Shape The Future Of Dentistry

The Medical Futurist

Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. For patients, it promises more accurate care and better outcomes. How about having a teledentist consultation?

Patients 126
article thumbnail

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law Blog

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers.

article thumbnail

Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

FDA Law Blog

On the other hand, the Draft Guidance states that a significant change to the design of a printed circuit board (PCB) in a multi-parameter physiological patient monitor, with arrhythmia detection alarms for use in a hospital environment, would not be appropriate for inclusion in a PCCP. Draft Guidance at 34.

Medical 59
article thumbnail

An Arm and a Leg: The Prescription Drug Playbook, Part I

Physician's Weekly

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. This is a, you know, board certified pediatric neurologist who’s been seeing this patient for years. But a lot of patients say, like Bob would: My doctors and I had already DONE all this checking. Dan: We see it all the time.

article thumbnail

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution.

Illness 107
article thumbnail

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law Blog

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. By Dara Katcher Levy & Sara W. Koblitz & Jeffrey N. Please bear with us.) it is illegal to import. 70,796, 70,800 (Dec.