FDA Law

JANUARY 4, 2022

We summarized the major revisions to the Code in a blog post when it was released in August 2021. Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. We blogged about the Alert here ). Department of Health and Human Services (OIG).

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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. Reynolds Vapor Co. , Nor does the analysis limit the statute’s scope to retailers. In Diamond Alternative Energy, LLC v.

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Government Manufacturing Provider IT 59

FDA Law

JULY 2, 2025

Our team assists clients with a wide variety of quality and manufacturing regulatory topics for drugs and biologics. Types of matters include: Developing regulatory strategy for manufacturing and related issues that arise in product development programs. Specifically, manufacturing/testing procedures and compliance with cGMPs.

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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. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). & Mfrs.

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FDA Law

MARCH 6, 2024

FDA Law Blog readers can use discount code S10-866-866L24.S Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. More information about the conference can be found here. S for reduced registration fees.

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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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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.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

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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.

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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. & Douglas B.

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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

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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FDA Law

MARCH 19, 2024

is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers.

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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.

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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.

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Manufacturing Medical Provider IT 52

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 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.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

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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.”

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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 ). The regulation became effective on December 18, 1978 and was codified under part 820.

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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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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.

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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.

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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. This blog will continue to monitor how DOJ and the courts analyze the intersection between the FDCA and the FCA.

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Manufacturing Government Healthcare Management 72

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

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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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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FDA Law

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA recommends including only a limited number of modifications in the PCCP.

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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.

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FDA Law

SEPTEMBER 3, 2024

Gibbs — Thank you to readers of this blog. Given the high rate of innovation in the device industry, including the evolving field of AI, we expect more manufacturers to either submit De Novo classification requests or rely on those for their 510(k) devices. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N.

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Manufacturing Medical Provider IT 69

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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FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

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Manufacturing Provider Medical IT 98

FDA Law

APRIL 8, 2025

Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. This facilitated generic manufacturers access to samples of brand-name drugs not readily available through normal market channels for generic drug development.

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FDA Law

SEPTEMBER 27, 2022

The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements. The program is currently not accepting applications for antibody tests (HPM has blogged previously about FDA’s Monkeypox Policy here ).

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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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FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Background. Pfizer set the price of tafamidis at $225,000 for each one-year course of treatment.

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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. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer.

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FDA Law

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

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