Article Manufacturing Medical Provider 
The Medical Futurist
JUNE 17, 2025
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. Can you imagine that you might get your 3D-printed prosthesis in an hour instead of 4-5 sessions at the dentist?
Physician's Weekly
JUNE 18, 2025
The patient was enrolled in a cost-sharing program that reduced her out-of-pocket expenses by 70%, allowing her to access the medication. In addition, she received counseling on medication use, lifestyle changes, and nutritional goals. They published their insights in Nature Medicine.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law
DECEMBER 12, 2022
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).
FDA Law
NOVEMBER 20, 2024
Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.
FDA Law
AUGUST 15, 2021
Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. label use if the manufacturer knew about it. By Jeffrey K. 801.119, 801.122, and 1100.5
FDA Law
JUNE 22, 2025
While in the present case, the manufacturer, retailer, and trade association were all part of the same lawsuit, nothing in the Court’s decision requires that the applicant be a party to such a challenge. Reynolds Vapor Co. , Nor does the analysis limit the statute’s scope to retailers. In Diamond Alternative Energy, LLC v. McKesson Corp.,
FDA Law
MAY 29, 2025
Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. Another article about CLAT (available here ) suggests FDAs model will continually learn and improve over time. By Adrienne R. We have all seen AI failures online, some amusing (e.g.,
Expert insights. Personalized for you.
126 
Let's personalize your content