FDA Law Blog

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.

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FDA Law Blog

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 Blog

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Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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

APRIL 14, 2025

The product is then shipped back to India for the next manufacturing stages. After shipment through Europe and Asia, the journey continues through several locations within the United States, specifically New Jersey, for the final stages of manufacturing. Quality testing and stocking occur elsewhere, such as within the European Union.

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Physician's Weekly

JUNE 15, 2025

However, their clinical use is limited by the lack of standardized good manufacturing practice (GMP)-compliant isolation and conservation protocols. EVs loaded with PTX were manufactured by adding the drug to the culture medium of MSCs before supernatant collection.

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NPR Health - Shots

APRIL 10, 2023

Strep throat is more prevalent this year, and amoxicillin manufacturers didn't make enough of the antibiotic to go around. Image credit: Luis Alvarez/Getty Images)

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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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NPR Health - Shots

FEBRUARY 4, 2023

Gas utilities and cooking stove manufacturers knew for decades that burners could be made that emit less pollution in homes, but they chose not to. That may may be about to change. Image credit: Sean Gladwell/Getty Images)

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NPR Health

DECEMBER 21, 2024

The Food and Drug Administration has told food manufacturers the psychoactive mushroom Amanita muscaria isn't authorized for food, including edibles, because it doesn't meet safety standards. Image credit: Karl-Josef Hildenbrand)

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Physician's Weekly

JUNE 18, 2025

They proposed the following solutions: Facilitate greater access to improve cost-sharing Remove anti-obesity pharmacotherapy with less efficacy and undesirable side effects (such as orlistat) Governmental Regulatory Agencies Potential solutions addressing stigma and safety concerns among governmental regulatory agencies include the following: Follow (..)

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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

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

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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Alabama Academy of Family Physicians

MAY 15, 2025

Pharmacy benefits managers would be further required to pass on 100 percent of rebates received from drug manufacturers to the health benefit plans for which they provide services.

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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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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

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.

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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 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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Medical Xpress

APRIL 8, 2023

Messenger Ribonucleic Acid (mRNA) as a therapeutic approach is gaining momentum due to its ability to be rapidly manufactured and its promising outcomes. mRNA-based vaccines, for instance, played a crucial role in the fight against COVID-19 in many parts of the world.

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FDA Law Blog

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 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.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).

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New South Family Medicine and MedSpa

OCTOBER 13, 2020

There are formulations manufactured without egg products, so the worry of egg-allergy should not be a reason to abstain from a flu shot. Every person over the age of 6 months should get a flu shot.

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FDA Law Blog

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. Municipal Regulation § 8305.11.

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The Medical Futurist

JUNE 17, 2025

Computer-assisted design (CAD) and computer-assisted manufacture (CAM), including 3D-printing, are already revolutionising the sector; they are turning them into low-cost, more effective digital labs. This image is then relayed to a machine that manufactures the crown right in the office.

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NPR Health

MAY 19, 2025

But manufacturers face challenges that could drive prices higher. The MAHA movement loves the idea of getting rid of synthetic dyes in foods. Image credit: BWFolsom/iStockphoto)

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Medical Xpress

APRIL 11, 2023

With a growing body of scientific evidence illustrating the influence of gut microbiota on human health, researchers from AIage Life Science, a probiotics manufacturer in China, investigated the microflora inhabiting the guts of the world's healthiest people—centenarians.

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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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Medical Xpress

DECEMBER 22, 2022

Japan has approved a blood test kit to diagnose Alzheimer's disease, its manufacturer announced on Thursday, a rare advance in tackling a condition that affects tens of millions worldwide.

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Medical Xpress

DECEMBER 7, 2022

US e-cigarette manufacturer Juul Labs said on Tuesday it had reached a settlement with about 10,000 plaintiffs in California after the company was accused of marketing its products to teenagers.

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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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Medical Xpress

MAY 1, 2023

Mejias had been taking a drug to treat a rare skin disease for about two years when its manufacturer effectively cut off his supply.

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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

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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Doctor Rachel

OCTOBER 25, 2017

Lavandin is easier to grow than fine lavender and produces more flowers per plant—making it less expensive to manufacture its essential oil. It is used in almost all lavender scented products. Traditionally, lavender was gathered by women and children on the slopes of the mountains in Provence.

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FDA Law Blog

JANUARY 9, 2025

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. FD&C Act 501(j). But what exactly constitutes delaying, denying, limiting or refusing an FDA inspection?

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