FDA Law Blog

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Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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 Blog

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 Blog

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 Blog

MAY 6, 2024

The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions. are cybersecure.

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FDA Law Blog

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

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. McKesson Corp.,

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FDA Law Blog

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 Blog

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 acknowledgment will include an FDA-assigned identification number for the allegation report.

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FDA Law Blog

APRIL 8, 2025

DPD met all of the GDUFA commitments to publish policy documents (Section IX of the GDUFA III Commitment Letter ) and published many others the Division determined would provide clarity to the generic drug industry. Providing significant policy support to the annual update of the Orange Book Preface. 314.150(c).

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FDA Law Blog

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 Blog

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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FDA Law Blog

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 Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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FDA Law Blog

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 Blog

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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FDA Law Blog

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 Blog

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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FDA Law Blog

MAY 29, 2025

Therefore, it seems reasonable that AI models could be trained on the data, provide useful insights to reviewers, and speed up review times. 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 Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change. The fate of the PR is far from certain.

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FDA Law Blog

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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Plum Health

AUGUST 30, 2024

Why Plum Health Direct Primary Care Is Your Best Option for Affordable Ozempic and Wegovy At Plum Health Direct Primary Care, we provide an innovative solution to the high cost of medications like Ozempic and Wegovy. Speak with your Plum Health Provider : As soon as you join, we’ll help discuss if Ozempic is right for you.

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Medical Xpress

APRIL 11, 2023

In the process of organoid manufacturing, bioprinting technology can not only facilitate the creation and maintenance of complex biological 3D shapes and structures, but also allow for standardization and quality control during production.

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FDA Law Blog

FEBRUARY 9, 2024

Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates.

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FDA Law Blog

OCTOBER 4, 2023

The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. Order at 24.

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FDA Law Blog

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.

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FDA Law Blog

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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The Medical Futurist

JUNE 21, 2025

It will break language barriers These M-LLMs will easily facilitate communication between healthcare providers and patients who speak different languages, translating between various languages in real time. Just as we’ve seen how live translation works with ChatGPT-4o.

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FDA Law Blog

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 Blog

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. 23-1038 (Apr.

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FDA Law Blog

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

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FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” By Philip Won & Jeffrey K. It applies whether the software is the entire device (i.e.,

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FDA Law Blog

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. CMS will develop a new online portal for manufacturers to review their reports, submit Suggestions of Error, and make rebate payments.

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FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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FDA Law Blog

AUGUST 6, 2021

We are similarly at a loss to understand the purpose of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. This new policy goes into effect on August 25, 2021. Pharmaceutical companies do not need to do this.

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FDA Law Blog

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 provides support to manufacturers by providing both analytical and clinical testing that meets FDA requirements for an EUA submission.

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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

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