2019 Individual Medical Relationship 
FDA Law Blog
OCTOBER 2, 2023
However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.
FDA Law Blog
MAY 8, 2023
Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.
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FDA Law Blog
JANUARY 6, 2022
Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.C. §
FDA Law Blog
JANUARY 6, 2022
Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.C. §
FDA Law Blog
JUNE 23, 2021
As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. By Asking Them. When a Patient Speaks (Sept. 25, 2014).
GeriPal
NOVEMBER 9, 2023
The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. We’re doing a lot of interactive relationship building. If they’re a beginning fellow, that’s a very different coaching situation than coaching the chief medical officer or the president of a medical center.
GeriPal
MAY 18, 2023
Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.
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