FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. intrusion [into] the doctor-patient relationship. What is going on here? Draft Guidance.

Manufacturing 52

Manufacturing Provider Patients Medical 52

FDA Law Blog

OCTOBER 14, 2021

Given these onerous requirements, it is not a surprise that RAS device manufacturers have not sought clearance for RAS devices for oncology procedures. It would also be beyond the scope of what RAS device manufacturers are intending to offer, which is a better surgical tool, not a therapeutic for cancer. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(f) 2(f) at 9-10.

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. Is there any relationship between frailty and urinary incontinence?

IT 120

IT Patient-Centered Patients Clinic 120

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? I love that.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law Blog

MAY 26, 2025

While ensuring that a pre-enforcement challenge is properly presented to a court is not a simple task, it can be done, and for those interested, there may be much to challenge. MedImmune, Inc. Genentech, Inc., 118, 129 (2007) (quoting Abbott Labs v. Gardner , 387 U.S. 136, 152 (1967)). The memo also instructs U.S.

Manufacturing 59

Manufacturing Provider Medical General Practice 59