FDA Law

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA recommends including only a limited number of modifications in the PCCP.

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FDA Law

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). Drug or biologic sponsors should engage with manufacturers of DHTs to ensure appropriate evidence has been established for the DHTs before use in a clinical study.

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FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3)

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Manufacturing Provider Medical IT 98

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). Meanwhile, manufacturers are on the hunt to find their quarry before their customers do it for them.

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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

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

FEBRUARY 21, 2024

It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.

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FDA Law

AUGUST 23, 2022

The study represents the most robust attempt at understanding the performance of serial use of rapid antigen tests for SARS-CoV-2 detection among asymptomatic individuals in the U.S. The low viral loads were most likely due to individuals infected with the Omicron variant. That could happen again.

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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

NOVEMBER 14, 2022

Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). The facility fee applies to a single manufacturing facility. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.

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FDA Law

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Were DEA to reschedule marijuana in schedule III, the agency and registrants would have to straddle the requirements of two schedules by requiring manufacturing quotas and import/export permits. 811(d) and U.S. 811(d) and U.S.

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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

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

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FDA Law

DECEMBER 12, 2023

RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats. (Apologies to our readers—word play is FDA Law Blog’s catnip.) Formulating cat food based on RSS methodology is a more recent dietary strategy whose principles apply to all urolith types.

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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. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.

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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

SEPTEMBER 27, 2023

The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).

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FDA Law

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. We’ve previously blogged about this ongoing battle here , here , here , and here. By Sophia R.

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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. At the same time, if the RLD prescription drug and its generics have gone away, these individuals would not be able to obtain the medication by prescription from their healthcare provider. 105288 (Dec.

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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.) Defendants may also seek en banc review of the decision from the full Ninth Circuit. HCT/Ps that meet the four criteria under 21 CFR 1271.10(a), Robbins , 519 U.S.

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FDA Law

SEPTEMBER 12, 2024

Walsh — While we hope readers of the Blog, as our clients and friends, come out of any FDA inspection with a clean bill of health, we know that based on FDA FY2024 data to date, approximately 40% of inspections of medical device companies end up classified as voluntary or official action indicated (VAI or OAI). By Adrienne R.

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Manufacturing Provider Medical IT 59

FDA Law

JUNE 22, 2023

By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. FDA, in turn, filed its own statement “to address misinformation” (see FDA’s statement here ). lay users). seeking treatment).

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Manufacturing Clinic IT Medical 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

OCTOBER 6, 2022

Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 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 gene therapy chemistry, manufacturing, and controls. vector manufacturing for a transgene vector).

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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? It is focused on excimer lasers with premarket application (PMA) approval for LASIK in product code LZS. This proposal is not, however, simply advice for preparation of an application for a new device. Public Comments.

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Manufacturing Provider Patients Medical 52

FDA Law

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. Instead, the exemption from the NTL criteria now applies to an individual food, or a mixed product that is comprised of one or more of the foods recommended by the DGs (i.e.,

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Individual Manufacturing Provider IT 52

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

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.

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FDA Law

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. PFI has noted that it is not feasible to develop and label products for an individual state.

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FDA Law

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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Government IT Manufacturing Illness 64

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

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. §

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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.”

Manufacturing 40

Manufacturing IT Medical Individual 40

FDA Law

FEBRUARY 27, 2023

In an erratum filed to the deposition of an official previously self-identified as the Chief FOIA Officer, the government stated that the individual was in fact, not the Chief FOIA Officer for DEA but Chief of the FOIA/PA Unit at DEA. Merrick Garland, et. al , Case No. 4:2022-cv-02396 S.D.

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Manufacturing Government Individual IT 45

FDA Law

SEPTEMBER 6, 2022

Although a sponsor of an individual patient expanded access trial may only recover direct costs associated with making the drug available, a sponsor of an intermediate-size patient population expanded access IND, or a treatment IND may also recover administrative costs directly associated with the expanded access use.

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Clinic Manufacturing Patients IT 52

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. In response, FDA memorialized its intention to use some of the new tools explored during the pandemic and potentially make them more permanent fixtures of facility inspections (e.g.,

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law

OCTOBER 5, 2022

The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).

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