FDA Law Blog

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure.

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Physician's Weekly

JUNE 18, 2025

The patient was enrolled in a cost-sharing program that reduced her out-of-pocket expenses by 70%, allowing her to access the medication. In addition, she received counseling on medication use, lifestyle changes, and nutritional goals. They published their insights in Nature Medicine.

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Alabama Academy of Family Physicians

MAY 15, 2025

The updated tax credit seeks to incentivize physicians to serve in underserved rural communities, addressing longstanding healthcare disparities and bolstering access to medical care for Alabama’s rural residents. What Happened: The Senate Committee on Finance and Taxation Education did not meet to discuss the bill.

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Medical Xpress

NOVEMBER 22, 2022

New research shows that two thirds of all packaged foods on supermarket shelves contain added sugars—including some you might not expect—and they're hard to identify, thanks to confusing terms used by food manufacturers.

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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.

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Medical Xpress

APRIL 14, 2023

New research shows that several anti-obesity medications could be manufactured and profitability sold worldwide at far lower estimated lower prices compared to their high costs, according to a new study in Obesity, The Obesity Society's (TOS) flagship journal.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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Medical Xpress

JANUARY 20, 2023

Manufacturers, through a loophole in the law, can use an unsafe medical device as a basis for U.S. Food and Drug Administration (FDA) authorization to sell the device, a new Yale-led study finds.

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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

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. 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.

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FDA Law Blog

MARCH 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Now, FDA is granting a waiver of annual registration fees, per the draft guidance for Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance. The catch: the company has to be small and bankrupt.

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FDA Law Blog

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. 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. By Adrienne R.

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The Medical Futurist

JUNE 21, 2025

Large language models will soon find their way in to everyday clinical settings , simply because the global shortage of healthcare personnel is becoming dire and AI will lend a hand with tasks that do not require skilled medical professionals. Current medical AIs only process one type of data, for example, text or X-ray images.

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Plum Health

AUGUST 30, 2024

Mike to discuss affordable GLP-1 medication! These are groundbreaking medications that not only help regulate blood sugar but also support weight loss. Ozempic is classified as a glucagon-like peptide-1 ( GLP-1) agonist , a type of medication that imitates the actions of a gut hormone known as GLP-1.

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FDA Law Blog

MARCH 25, 2025

Lenz, Principal Medical Device Regulation Expert Last year, FDA issued a letter to the medical device industry warning medical device firms of concerns related to fraudulent and unreliable laboratory testing data in premarket submissions, which we blogged about here. By Adrienne R.

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The Medical Futurist

JUNE 21, 2025

However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Scientists at Columbia University Medical Center and the University of Iowa used CRISPR to repair a genetic mutation responsible for retinitis pigmentosa in induced pluripotent stem cells derived from a patient with the disease.

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Medical Xpress

FEBRUARY 9, 2023

New research in the journal Manufacturing & Service Operations Management finds that pooling resources to have cross-trained fire-medics respond to both emergency medical calls and fire incidents, rather than having firefighters respond to fires and emergency medical personnel respond to medical incidents, can save more than $3 million a year.

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Physician's Weekly

JUNE 12, 2025

Food and Drug Administration (FDA) after the manufacturer, Church & Dwight Co., Swabs that are contaminated with fungi can lead to serious infections, especially in children, people with weakened immune systems or those with other medical conditions. health officials said. The recall was announced by the U.S.

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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 Blog

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection. FD&C Act 501(j).

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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

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

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FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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FDA Law Blog

FEBRUARY 7, 2023

Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market. Part 830), post-market surveillance studies (Section 522 of the FD&C Act), medical device tracking (21 C.F.R.

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Annals of Family Medicine

NOVEMBER 20, 2024

Setting: 3 academic medical centers. FIT manufacturers should develop very clear directions for patients. Study Design/Analysis: Prospective; participants completed 5 unique FITs according to those most commonly used. Population Studied: 2148 individuals aged 50 to 85 years scheduled for screening or surveillance colonoscopy.

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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

AUGUST 16, 2022

Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. By Douglas B. Mr. Cruse pledged that the frequency of these inspections would increase.

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FDA Law Blog

NOVEMBER 29, 2023

Focused and Bounded This guiding principle recommends that the PCCP describe a specific planned change that is consistent with the claimed intended use and intended purpose of the Machine Learning Medical Device (MLMD). The plan should identify the methods for verifying and validating the change.

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FDA Law Blog

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. The Safe Medical Devices Act of 1990 provided FDA with the authority to include design controls in the regulation.

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FDA Law Blog

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 Blog

AUGUST 15, 2021

Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. 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.

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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 30, 2021

By Philip Won — On June 17, 2021, FDA has released a discussion paper to discuss cybersecurity issues related to the servicing of medical devices. FDA is now expanding its cybersecurity effort in servicing of medical devices. What are the cybersecurity challenges and opportunities associated with the servicing of medical devices?

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FDA Law Blog

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

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FDA Law Blog

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. By Adrienne R. Comments on the Draft Guidance may be submitted until November 20, 2024.

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FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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