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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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. This is unproductive.

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FDA Law

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.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., This guidance document is still in effect today.

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FDA Law

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. As readers of this blog well know, there is no private right of action to enforce the FDCA.

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FDA Law

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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FDA Law

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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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. Javitt & Jeffrey N.

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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.” We have recently blogged on this topic (“ Is my software a medical device? ”). By Philip Won & Jeffrey K.

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FDA Law

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. Gonzalez & Lisa M. SCH : LDT, approved by NYS CLEP.

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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

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. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.

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FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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FDA Law

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

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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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FDA Law

OCTOBER 6, 2021

By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. Code Ann. §

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FDA Law

NOVEMBER 7, 2021

Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). By Faraz Siddiqui & Alan M. Last week, the U.S. District Court for the Southern District of Indiana decided several substantive motions in Eli Lilly & Co.

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FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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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

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

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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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

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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FDA Law

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered. Change to the IVD definition First, the mechanics of the change. direct-to-consumer tests, tests for use in a public health emergency).

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FDA Law

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale.

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FDA Law

MAY 3, 2021

We thought this would be a good time to post a series of blog posts focusing on DEA inspections and how registrants should prepare for and manage them, with a list of registrant do’s and don’ts. We will discuss these actions in more detail in later blog. 44,710, 44,716 (July 24, 2020).

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FDA Law

OCTOBER 14, 2024

At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF).

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FDA Law

MARCH 1, 2023

FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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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. One unit equals one tablet, capsule, patch, syringe, milliliter, or gram.” 151.066, Subd.

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Hospital Manufacturing Specialization Medical 52

FDA Law

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

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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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FDA Law

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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FDA Law

JUNE 22, 2023

CDRH may express concerns that patients will not understand when the test is appropriate for them, that they will misinterpret or overly rely on results, or that they will forego or delay visits to a doctor. By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. lay users). seeking treatment).

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FDA Law

FEBRUARY 15, 2023

It is expected that, during these instances, patient risk from radiation exposure can be mitigated and minimized. has been modified so that manufacturers of diagnostic x-ray products no longer need to submit initial (§ 1002.10), supplemental (§§ 1002.11), abbreviated (§ 1002.12) and annual reports (§ 1002.13).

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FDA Law

OCTOBER 2, 2024

A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized. Change Guidance at 8. Draft Guidance at 34. A PCCP may also be submitted as part of a De Novo application.

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Medical Specialization Manufacturing IT 59

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. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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Manufacturing Patient-Centered Provider Telehealth 59

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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