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A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

FDA Law

MAY 29, 2025

According to the global consulting group ICF, the pilot used an ICF-developed Computerized Labeling Assessment Tool (CLAT) to read drug labels and pinpoint specific items for review, with the goal of improving the effectiveness of the drug labeling review. We have all seen AI failures online, some amusing (e.g.,

Manufacturing

Manufacturing Patient-Centered Medical Management

FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

FDA Law

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. FDA), and to generate data in a format that would streamline FDAs review.

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Webinars

How to Start Virtual Care the Right Way: A Proven Roadmap for 2025 and Beyond

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Trending Sources

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

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

Webinars

How to Start Virtual Care the Right Way: A Proven Roadmap for 2025 and Beyond

MORE WEBINARS

PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

Specialization

Specialization Manufacturing Education Provider

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

Manufacturing

Manufacturing Engineering Clinic Provider

Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

FDA Law

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

Consulting

Consulting Manufacturing Provider Specialization

What To Do When You Receive a DEA Order to Show Cause

FDA Law

APRIL 22, 2025

The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show Cause (or OSC) from DEA. Which option is right for you is a decision that is best made after consulting with experienced counsel. What Is an Immediate Suspension Order?

Government

Government Provider Consulting Manufacturing

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works.

Patient-Centered

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K.

Management

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K.

Management

Management Consulting Provider Physicals

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing

Manufacturing Provider Physicals Electronics

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law

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.

Manufacturing

Manufacturing Medical Appointment Patient-Centered

FDA-Approved Labeling: Is Enough Enough?

FDA Law

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

Manufacturing

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Primary Care Digest

A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

Webinars

Trending Sources

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

Webinars

PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

What To Do When You Receive a DEA Order to Show Cause

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA-Approved Labeling: Is Enough Enough?

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