FDA Law Blog

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.

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Manufacturing Provider Medical IT 98

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 Draft Guidance.

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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. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. I don’t see those perspectives as incompatible. Everybody ages.

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IT Patient-Centered Patients Clinic 120

FDA Law Blog

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

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

The clear intended message from the EO and the DOJ memo is that individuals and entities who engage in conduct within their scope may be targeted for criminal investigation and prosecution. Such a message may understandably deter the targeted conduct to avoid such a risk. MedImmune, Inc. Genentech, Inc., Gardner , 387 U.S. 136, 152 (1967)).

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Manufacturing Provider Medical General Practice 59