Remove 2014 Remove Government Remove Medical Remove Provider
article thumbnail

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). use in education, construction, art, and jewelry).

Medical 98
article thumbnail

Direct Primary Care - Role for the Future of Healthcare

The Direct Doctors Difference

Looking back to 2014, when we began, there were less than 100. Doctors (and other types of “providers” of healthcare) are tasked with seeing 20-25 patients in an 8 hour day, writing notes that are geared toward insurance billing, and charging for every extra they can manage - all to make the corporate system more profitable.

Insiders

Sign Up for our Newsletter

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

article thumbnail

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). use in education, construction, art, and jewelry).

Medical 75
article thumbnail

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64
article thumbnail

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d

article thumbnail

Approaches for Quelling Stigma related to COVID-19

BMJ

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. 2014 (28 August). National involvement is also needed to facilitate these efforts. doi:10.3389/fcomm.2020.00039

article thumbnail

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

Clinic 64