FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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Manufacturing Engineering Clinic Provider 59

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

FEBRUARY 5, 2024

She also provides consulting services for state licenses, as well as regulatory due diligence concerning licensing requirements, primarily for pharmaceutical manufacturers, wholesale distributers, and pharmacies. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.

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Consulting Manufacturing Government Provider 45

FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. If a submitter believes that certain testing described in the draft guidance does not apply to their device, they should provide a rationale in the 510(k) submission.

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Manufacturing Engineering Clinic Provider 45

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

MARCH 20, 2022

To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. Almost all recalls are conducted on a voluntary basis by the manufacturer. Product coding (e.g.,

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Electronics Manufacturing Provider IT 40

Physician's Weekly

JUNE 19, 2025

Back in February, we asked you, our listeners, to tell us how you’ve managed when your prescriptions got really expensive. Claire: All of that, but the celebrity factor isn’t really what makes Cost Plus different: The company buys meds direct from manufacturers, and adds 15 percent to their wholesale cost. Dan: I KNOW!

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FDA Law Blog

JUNE 30, 2024

Lenz brings a wealth of experience, having provided consulting to medical device and combination product manufacturers on a wide range of pre and postmarket regulatory topics. The program is structured to provide early identification and mitigation of risks, as well as aligning expectations regarding evidence generation.

Medical 52

Medical Consulting Manufacturing Provider 52

FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” The task force facilitates communication between device manufacturers and payors.

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Manufacturing Medical Appointment Patient-Centered 45

GeriPal

MAY 8, 2025

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? And those of us who work in palliative care are more familiar with the 5ht3 receptor, which we use for nausea management. So I can say anything I want. So 5ht2 was.

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Illness IT Patient-Centered Patients 107