Blog, Consulting and Manufacturing

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.

Manufacturing

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Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling

FDA Law

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Were DEA to reschedule marijuana in schedule III, the agency and registrants would have to straddle the requirements of two schedules by requiring manufacturing quotas and import/export permits. Whether DEA believes the U.S.

Manufacturing

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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. As we have previously discussed, the Third Party 510(k) Review Program is not widely used.

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Webinars

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

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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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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 ).

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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. We find that this information is noteworthy for manufacturers to consider.

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

FDA Law

DECEMBER 7, 2023

We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing. This speech is an annual victory lap for CPB’s enforcement achievements, and this year included much discussion about the Branch’s Voluntary Self Disclosure (VSD) policy.

Consulting

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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.

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. 30, 2023; Public workshop on advancing innovative manufacturing technology, by end of FY 2023; Publish advancing innovative manufacturing technology strategy document, by Sept.

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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. Accountability Audit.

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. Accountability Audit.

Management

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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

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“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

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FDA-Approved Labeling: Is Enough Enough?

FDA Law

AUGUST 21, 2023

Specifically, the Court explained, because “[t]he Pregnancy Warning Regulation simply does not speak to whether a further warning related to a drug’s use during pregnancy can be added to the general Pregnancy Warning on a drug label, whether added by the FDA or added by a manufacturer,” the ”regulation does not, therefore, preempt state law.”

Manufacturing

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DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. Updating the list, DEA consulted law enforcement officials, forensic laboratory authorities, intelligence groups, drug signature and profiling programs, and international organizations.

Specialization

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Primary Care Digest

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

Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling

Webinars

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

Webinars

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

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?

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

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