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

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FDA Law

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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IT Manufacturing Provider Medical 104

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. Ozempic injection pen.

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Primary Care Insurance Diabetes Manufacturing 52

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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Manufacturing Patients IT Medical 99

FDA Law

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. Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

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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.

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FDA Law

JUNE 2, 2025

As HPM argued in both the groundbreaking citizen petition Jeffrey Gibbs filed thirty-two years ago and the papers we filed on behalf of our clients, Dr. Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices.

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FDA Law

MAY 29, 2025

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

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of the approximately $13,000 annual copay. Pfizer, Inc. July 25, 2022. Background.

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My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Switching to renewable energy.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

FDA Law

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

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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FDA Law

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.” Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e.,

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FDA Law

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. Many sponsors want to reduce animal testing and, therefore, welcome the approach.

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Provider Medical Manufacturing Consulting 59

FDA Law

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

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FDA Law

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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FDA Law

OCTOBER 2, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Gail H. By Adrienne R. Change Guidance at 8.

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FDA Law

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. By Steven J. Gonzalez & Lisa M.

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FDA Law

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background.

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Manufacturing Patient-Centered Healthcare Utilities 83

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Patient-Centered Patients Clinic 120

FDA Law

MAY 31, 2021

PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance. Manufacturers provide patient savings programs at the pharmacy counter to defray the patient’s out-of-pocket costs such as co-pays and deductibles. In December 2020, CMS published a final rule making several changes to the MDRP regulations.

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Manufacturing Insurance Patients IT 52

FDA Law

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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Manufacturing Provider Patients Medical 52

FDA Law

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000. One unit equals one tablet, capsule, patch, syringe, milliliter, or gram.” 151.066, Subd.

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FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products are sharing the digital moment with those classified solely as medical devices.

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Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Avdel amicus brief).

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FDA Law

FEBRUARY 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Allyson B. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products as well. It is expected that, during these instances, patient risk from radiation exposure can be mitigated and minimized.

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Manufacturing Electronics Medical Provider 52

FDA Law

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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FDA Law

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity. By McKenzie E. Cato & Jeffrey N.

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Manufacturing Clinic IT Medical 59

FDA Law

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. The proposed rule has a 60-day comment period for stakeholders. This proposed rule is a long-time coming.

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Manufacturing Clinic Screening Healthcare 59

FDA Law

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Medical Electronics Manufacturing Utilities 64

FDA Law

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year. We previously blogged about this lawsuit last year.

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Insurance Manufacturing Patient-Centered Individual 40

FDA Law

APRIL 11, 2022

As background, Medtronic manufactures the MiniMed 600 series insulin infusion pumps. Specifically, FDA criticized the risk calculation formula because it used the total shipment of affected product , which “underestimates the probability of occurrence because the number of products shipped includes devices not in use by patients (e.g.,

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FDA Law

MARCH 31, 2024

The proposed rule extends far beyond the scope of any legislative proposals and would threaten access to reliable tests for children and patients with rare diseases.” He emphasized that FDA regulatory oversight should focus on those tests that pose the highest risk to patients. These are areas where “revenue is modest,” she said.

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Patients Medical Provider Manufacturing 64

FDA Law

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Reading through the “Findings” section of S. inventors to compete. But there’s another side to this story.

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FDA Law

DECEMBER 15, 2024

In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. In general, a greater understanding and knowledge of the product and manufacturing process can reduce the number of PPQ lots that should be sufficient to qualify the performance of the manufacturing process.

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CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

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Patient-Centered Patients Manufacturing Provider 52

FDA Law

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. These clearances are based on short-term (30 day) patient follow up.

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