FDA Law

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).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

Clinic Clinical Practice Provider Utilities 64

The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. However, more recently, we have observed that DEA special agents are also becoming more involved in investigations of registrants, thus, raising the stakes for compliance. Background. DEA can seek administrative action, and working with U.S.

Management 52

Management Manufacturing Specialization IT 52

FDA Law

MAY 3, 2021

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. However, more recently, we have observed that DEA special agents are also becoming more involved in investigations of registrants, thus, raising the stakes for compliance. Background. DEA can seek administrative action, and working with U.S.

Management 40

Management Manufacturing Specialization IT 40

GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

IT 113

IT Provider Patients Families 113

FDA Law

JANUARY 22, 2025

And in all seriousness, the finalization of this guidance is somewhat historic given that industry has been relying on various versions of draft Good Reprint Practices guidance since 2009. In any event, you whippersnappers should look up the album No Jacket Required its a classic.) This final guidance (16 years in the making!)

Specialization 59

Specialization Medical IT Clinic 59

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. They got feedback. So did it matter?

Patient-Centered 77

Patient-Centered IT Hospital Patients 77