FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. The final rule emphasizes risk management activities and risk-based decision making.

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FDA Law

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. These recommendations come based on the latest National Institutes for Health (NIH) and University of Massachusetts Chan Medical School study which was funded by the NIH Rapid Acceleration of Diagnostics (RADx) program.

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FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background.

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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. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

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FDA Law

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. The insurer still accepts the manufacturer payment, but also collects the full deductible from the patient.

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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 ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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FDA Law

DECEMBER 12, 2023

We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.) RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats. Upper bound of 95% CI ≤ 2.5

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FDA Law

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Schedule IV substances are highly addictive and rarely used in medical practice while schedule I substances are also highly addictive, liable to abuse or convertible to drugs similarly addictive and liable to abuse. 811(d) and U.S.

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FDA Law

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

SEPTEMBER 12, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Anne K. For manufacturing and product-related observations especially, don’t forget to do a “right-left look” to identify if a similar issue has occurred with another product line offered by the company.

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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. 5429, the “ Medication Affordability and Patent Integrity Act.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

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FDA Law

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. In discussing these revisions, FDA clarified that an ACNU failure must be reported even if the failure does not cause or lead to inappropriate medication use or consumer harm. 105288 (Dec.

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FDA Law

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? Rather, it was about the assimilation of the full range of available medical data and information to assess how procedural risk generally should be conveyed to patients, regardless of the specific LASIK device being used.

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FDA Law

JULY 25, 2023

Nitrosamines are chemicals that can form during drug manufacturing, known by their scientific names as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The canary in the coal mine for nitrosamines was their 2018 appearance in blood pressure medications called sartans.

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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.

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FDA Law

OCTOBER 14, 2024

Note we do not discuss the cell expansion variety of this treatment further in this blog as the court quickly dispensed of it as obviously not subject to the SSP exception.) These procedures are offered to treat a variety of conditions, including Alzheimer’s, arthritis, asthma, cancer, etc.,

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FDA Law

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

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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.

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FDA Law

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

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FDA Law

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812(c)(c)(10).

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FDA Law

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

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FDA Law

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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FDA Law

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. Notable Dates and Timelines – New MAPP published, by Dec.

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FDA Law

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. analytical, clinical and stability).

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FDA Law

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. In that letter, FDA stated that it would “permit manufacturers.

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FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

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FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M.

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FDA Law

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

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FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). 2 infection. A follow up laboratory?run run molecular diagnostic (RT?PCR)

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FDA Law

JUNE 24, 2021

Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). By McKenzie E.

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FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

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FDA Law

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

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FDA Law

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. and lack accepted safety for use under medical supervision.

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FDA Law

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however.

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FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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FDA Law

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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