Remove 2019 Remove Manufacturing Remove Medical 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. Researchers in 2019 developed a machine learning method to accurately quantify immune cells in the vicinity of oral cancer cells.

Patients 126
article thumbnail

Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. FDA, Guidance for Industry, The Special 510(k) Program (2019). By Adrienne R. For 510(k) devices, a PCCP may be submitted only with a traditional or abbreviated application.

Medical 59
Insiders

Sign Up for our Newsletter

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

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions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

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

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

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

Physician's Weekly

When Bob changed jobs, the price tag for his daughter’s medication went through the roof. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary.

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. So medication adjustments.

Illness 107
article thumbnail

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.