FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

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 Draft Guidance.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

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. I don’t see those perspectives as incompatible. And the issues are essentially the same.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

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 Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

FDA Law

SEPTEMBER 20, 2021

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. As such, we present these programs and initiatives roughly in order of the newest and most substantial changes to more minor.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107