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. the wholesale distributor, repackager, relabeler). Draft Guidance III.B.2(d)

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Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

MAY 5, 2022

Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? I’m guessing not. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: (Singing).

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IT Screening Hospital Clinic 102

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. §

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Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 6, 2022

Two of the new questions added in the Draft Guidance (Q22 and Q23) address the fact that monitoring and other administrative “startup” costs, and manufacturing costs are often higher in the first year compared to subsequent years. These new Q & As explain that some sponsors may amortize costs.

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Clinic Manufacturing Patients IT 52

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. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

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Patient-Centered Manufacturing Clinic Provider 52

The Clinical Problem Solvers

NOVEMBER 6, 2023

The developing attitudes about food scarcity and deficit models, and mass media’s manufacturing consent, has to be challenged, especially because there is a deep and rich history of Black people as farmers, gardeners, and ranchers that belies what Chimamanda Ngozi Adichie calls the danger of a single story. is rooted in anti-Blackness.

Community 52

Community Manufacturing Patients Medical 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. We begin with a refresher on psilocybinwhat it is, how it might work, what conditions it may help treat (including demoralization), and how its typically administered. It’s there.

Illness 109

Illness IT Patient-Centered Patients 109

FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. We discuss the statute’s major provisions summarized below. Federal Research. Cannabis Researcher Registrations. Application Process. 21 U.S.C. §

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Medical Manufacturing Electronics Provider 64

FDA Law Blog

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling. complex public health issues within 100(!) The Assessment does not focus solely on safety.

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Chronic Disease Government Clinic Chronic Condition 59

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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Healthcare IT Education Community 130

FDA Law Blog

NOVEMBER 8, 2022

If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications. Getting Serious About Women’s Health in Medtech.

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Medical Manufacturing Patient-Centered Provider 59

FDA Law Blog

MAY 26, 2025

Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. Attorneys to investigate all suspected cases of FGM [female genital mutilation]under the banner of so-called gender-affirming care or otherwiseand to prosecute all FGM offenses to the fullest extent possible. MedImmune, Inc. Genentech, Inc.,

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Manufacturing Provider Medical IT 59