FDA Law

JUNE 30, 2025

DEA registrants include manufacturers, distributors, importers, exporters, practitioners, pharmacies, hospitals, and narcotic treatment centers who handle federally-controlled substances. Manufacturers must also report selected schedule III and IV psychotropic drugs quarterly. Note that we are not focusing on listed chemicals here.

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Manufacturing Electronics Hospital Provider 59

FDA Law

JUNE 22, 2025

While in the present case, the manufacturer, retailer, and trade association were all part of the same lawsuit, nothing in the Court’s decision requires that the applicant be a party to such a challenge. By JP Ellison — Last Friday, the Supreme Court delivered a trio of decisions making it easier to litigate against the federal government.

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Government Manufacturing Provider IT 59

FDA Law

MAY 30, 2024

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.

Manufacturing 59

Manufacturing Patient-Centered Government Hospital 59

FDA Law

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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IT Manufacturing Provider Medical 104

FDA Law

JUNE 18, 2025

Increasing domestic drug manufacturing as a national security issue. Although many of the initial criteria are broadly applicable, and FDA has not indicated that any single criterion is more important than any other, manufacturing in the U.S. Delivering more innovative cures for the American people.

Manufacturing 59

Manufacturing Clinic Provider IT 59

FDA Law

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. A foreign food manufacturer that refuses to permit entry of [FDA inspectors} to inspect such factory, warehouse, or other establishment can be subject to an import alert under section 807(b) of the FD&C Act.

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FDA Law

DECEMBER 12, 2022

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device.

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FDA Law

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state.

Manufacturing 59

Manufacturing Government IT Provider 59

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” This guidance document is still in effect today. The recent discussion paper is not a guidance document and FDA says it is not intended to convey any current policy.

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law

APRIL 18, 2023

Houck — In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances. Designation of 4-Piperidone as a List I Chemical, 88 Fed. 21,902, 21,907, 21,909 (to be codified at 21 C.F.R. a)(38) (Apr.

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Manufacturing IT 59

FDA Law

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

Manufacturing 59

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FDA Law

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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Supply Chain Manufacturing Provider IT 97

FDA Law

MARCH 7, 2024

Gibbs — Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales for the most recent tax year, are eligible for a reduced fee on those medical device submissions that require a user fee.

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Manufacturing Medical IT Provider 64

FDA Law

MAY 29, 2025

As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. Applying AI models to review large amounts of data from multiple manufacturers could help FDA identify early signals related to product quality and patient safety.

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Manufacturing Patient-Centered Medical Management 102

FDA Law

JANUARY 18, 2023

By Faraz Siddiqui — Last week, the Centers for Medicare & Medicaid Services (CMS) released a memorandum on how it intends to implement the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act (IRA) (see our blog post and slide deck on IRA). The memorandum also introduced the Program’s spanking new logo.

Manufacturing 59

Manufacturing IT Provider Government 59

FDA Law

SEPTEMBER 11, 2024

Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens. By John W.M.

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Manufacturing Management Complication Provider 105

FDA Law

JUNE 2, 2025

Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. The Warning Letter seems to echo this point.

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IT Manufacturing Government Clinic 64

FDA Law

MARCH 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ). It is noteworthy that the one-year anniversary of the proposed rule has come and gone.

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Manufacturing Management Medical Provider 105

FDA Law

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. FDA has resumed on-site inspections of foreign facilities focused on current Good Manufacturing Practices (cGMP) but has continued issuing records requests under Section 704(a)(4), which spurred this latest round of warning letters.

Manufacturing 52

Manufacturing Electronics IT Physicals 52

FDA Law

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.”

Manufacturing 105

Manufacturing Provider Management IT 105

FDA Law

APRIL 6, 2025

This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

IT 59

IT Manufacturing Provider Family 59

FDA Law

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

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Manufacturing IT Provider ER 115

FDA Law

NOVEMBER 29, 2023

See our prior blog post on the topic here. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change. Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks.

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FDA Law

OCTOBER 4, 2022

By Véronique Li, Senior Medical Device Regulation Expert — Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. This means there needs to be a better way to understand the outcomes of urgent issues. This is unproductive.

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Manufacturing Medical Provider IT 52

FDA Law

JANUARY 16, 2025

Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Richardson has been promoted to Director.

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IT Manufacturing Management Individual 59

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” This guidance document is still in effect today. The recent discussion paper is not a guidance document and FDA says it is not intended to convey any current policy.

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Medical Manufacturing Healthcare Government 75

FDA Law

MAY 6, 2024

For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions. Manufacturers are required to design, develop, and provide a “reasonable assurance” that both the cyber device and related systems (e.g., update servers, network connections, cloud, etc.)

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Medical Manufacturing Provider Management 105

FDA Law

JULY 20, 2021

listing “made,” “manufactured,” “built,” “produced,” “created,” or “crafted” in the United States or in America). As readers of our blog know, “Product of USA” and other country of origin labeling issues on meat and poultry products have been an issue of discussion in recent years. or the Egg Products Inspection Act.

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IT Electronics Manufacturing Individual 76

FDA Law

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

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IT Manufacturing Utilities Complication 52

Evergreen Family Medicine

MAY 2, 2025

Whether officer versus enlisted man, manufacturer or service industry versus governmental oversight agency, or physician versus health care administrator, the distrust and friction are instinctive. Life’s experience bolsters that skepticism.This blog won’t help to heal those feelings.

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Manufacturing Healthcare Management IT 40

FDA Law

AUGUST 8, 2023

All of these deviations discussed in FDA inspectional observations and Warning Letters have caused serious issues for manufacturers of APIs or finished drug products. Perhaps most importantly, the guidance concludes with examples of how manufacturers would apply this framework to Nitroso compounds.

Manufacturing 74

Manufacturing Electronics Provider Clinic 74

FDA Law

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.

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Government Manufacturing Individual IT 98

FDA Law

AUGUST 15, 2021

The proposal was to remove the “knowledge provision,” which had always seemed to problematically suggest that a manufacturer could be held responsible for off?label label use if the manufacturer knew about it. By Jeffrey K. Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices.

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Manufacturing IT Provider Government 93

FDA Law

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. We are not aware of a similar guidance for meeting requests from manufacturers of NDA drugs.

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Manufacturing Provider IT Management 45

FDA Law

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. As readers of this blog well know, there is no private right of action to enforce the FDCA.

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Manufacturing Government Healthcare Management 72

FDA Law

DECEMBER 1, 2024

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., for multiple violations observed during an inspection that occurred eight months ago. To be sure, this is not the first time that FDA has included the “Limiting Photography” observation in a Warning Letter.

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Management IT Manufacturing Provider 113

FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background.

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