FDA Law

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Manufacturing Electronics Provider Management 64

FDA Law

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

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. Registrants may withhold consent or, if given, can withdraw consent at any time.

Management 40

Management Consulting Provider Physicals 40

FDA Law

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. Registrants may withhold consent or, if given, can withdraw consent at any time.

Management 40

Management Consulting Provider Physicals 40

GeriPal

JUNE 20, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. But that combination is actually quite common, and it’s quite challenging to diagnose and manage, at least in the traditional sense. That can be incredibly informative.

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IT Patient-Centered Patients Clinic 120

FDA Law

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.

Electronics 40

Electronics Manufacturing Provider IT 40

The Clinical Problem Solvers

NOVEMBER 6, 2023

Between the years 2019 and 2021, Harrison served as Associate Editor—and later as Managing Editor—of Wear Your Voice Magazine. Physical Fitness.” Harrison currently serves as Editor-at-Large at Scalawag Magazine, is a co-host of the podcast “Unsolicited: Fatties Talk Back,” and one third of the video podcast “In The Middle.”

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Community Manufacturing Patients Medical 52