2019 Clinic Individual Relationship 
FDA Law Blog
OCTOBER 2, 2023
The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.
FDA Law Blog
JANUARY 6, 2022
In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 220(b)(2). (C)
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
MAY 8, 2023
In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).
FDA Law Blog
JANUARY 6, 2022
In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 220(b)(2). (C)
FDA Law Blog
JUNE 23, 2021
I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.
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. Beth: Right now, I’m actually just doing individual coaching, but we are writing a grant to start group coaching next year. What does it mean to you?”
The Clinical Problem Solvers
DECEMBER 20, 2021
Appreciate how intergenerational trauma may surface amongst Asian-Americans, and how these intergenerational relationships may also offer fertile ground for generating understanding. Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures.
Expert insights. Personalized for you.
64 
Let's personalize your content