NPR Health - Shots

FEBRUARY 3, 2023

EzriCare artificial tears are suspected to be the cause of an outbreak of the VIM-GES-CRPA strain of Pseudomonas aeruginosa, which the CDC said is the first outbreak of its kind in the U.S. Image credit: Janice Haney Carr/AP)

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FDA Law Blog

MAY 14, 2025

Schwartz In early April, Cellares became the first company to announce receipt of an Advanced Manufacturing Technology (AMT) designation from FDA. The types of supporting data and information to include with a request depend on the specific method of manufacturing and its proposed context of use.

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FDA Law Blog

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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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. The 2025 Alabama Legislative Session concluded on May 14 at midnight. What Happened: This legislation has been enacted into law.

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FDA Law Blog

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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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

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.

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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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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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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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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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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. I love lavender oil. And I like to just rub it on my wrists, to keep me calm and happy. I went to the lavender museum in Coustellet, France and learned some new things. liter of lavender essential oil!

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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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FDA Law Blog

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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FDA Law

JUNE 25, 2025

The proposed order is intended to significantly simplify the development of new dosage forms for oral monograph order drugs that, at this time, may be marketed only in tablets or capsules. The suitable reference product must be a capsule or tablet that is swallowed.

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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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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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Medical Xpress

MAY 17, 2023

The study is by Dr. Daniel Weghuber, Department of Pediatrics, Paracelsus Medical University, Salzburg, Austria, and Dr. Rasmus Sørrig, Novo Nordisk A/S (the manufacturer of semaglutide), Søborg, Denmark, and colleagues.

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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. 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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The Medical Futurist

JUNE 21, 2025

How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! What about the smell of the flowers? Without the wind blowing, only 10-20 metres. How about touching or tasting? Well, it depends on your arm’s length, but obviously not further than that. Globally 1.1

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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

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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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.

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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 means there needs to be a better way to understand the outcomes of urgent issues. This is unproductive.

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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

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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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. Other jurisdictions like D.C.

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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 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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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

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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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 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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FDA Law Blog

MAY 29, 2025

Another area for which AI models may be suited in the medical device space would be post-market data, such as Medical Device Reports, where the data submitted is in a more standardized format from manufacturer to manufacturer. FDA has been working for years to understand the complexity of AI and how to ensure it functions as intended.

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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

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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