FDA Law Blog: Biosimilars

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

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Advarra

DECEMBER 17, 2024

These companies are laying the groundwork for more sophisticated AI applications designed to transform clinical operations, improving both efficiency and productivity. As AI continues to evolve, its ability to transform the efficiency, quality, and scalability of clinical research will grow exponentially.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. On August 28 of this year, NPA sued FDA challenging FDA’s determination that NMN is excluded from the dietary supplement definition.

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Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. Managing regulatory submissions through increased product and process knowledge. The definition of the levels of reporting categories for such changes.

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The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e)

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FDA Law Blog: Biosimilars

JUNE 13, 2024

As we explained back in March , Teva had initiated Hatch-Waxman pre-launch patent litigation against Amneal for infringement of 5 Orange Book-listed patents reading on the device constituent (a metered dose inhaler) of Teva’s combination product ProAir HFA. b)(1) that drug product patents may be listed if they claim the “drug product.

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LifeSciVC

NOVEMBER 17, 2023

This year we start with a deep dive into the biomedical innovation across our industry – “putting the Big back into Big Pharma” with obesity and Alzheimer’s, and the state of play across other disease areas, industry R&D productivity, and the risks facing the sector.

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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FDA Law Blog: Biosimilars

APRIL 25, 2023

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application.

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Agency IQ

OCTOBER 6, 2023

The EPA has a new, enforceable definition for PFAS. As part of its new PFAS reporting rule, the Environmental Protection Agency has published a newly enforceable definition of PFAS that significantly increases the number of chemicals covered by the definition, and therefore, the rule. What does it actually cover?

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Agency IQ

MAY 10, 2024

FDA holds the line on remanufacturing definitions in newly finalized guidance Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications. That draft guidance came out in 2021.

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Perficient: Drug Development

NOVEMBER 6, 2023

Moving from the traditional monolithic CMS model to composable does allow you to pick and choose “best in breed” products, but it can lead to confusion and uncertainty. If there are tools that definitely aren’t going anywhere, make a note of those. These are key metrics in determining which products will yield the largest ROI.

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PLOS: DNA Science

DECEMBER 14, 2023

I don’t use scented products other than Pine-Sol, so this was all new to me. Before I dig into the science, I’ll relate taking a quiz on the Future Society website that would help me choose a product. ” Definitely Zen retreat, because Wendy meditates. Next, the screen asked me to describe Wendy.

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Perficient: Drug Development

NOVEMBER 20, 2024

Additionally, managing this approach requires structuring and maintaining numerous prompts and class definitions, adding to its complexity. ” Definition: A “BOOKING INQUIRY” is a message that directly involves: Booking a flight: Questions or assistance requests about reserving a new flight.

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Agency IQ

JUNE 28, 2024

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R. FDA replied that its definition of strength including concentration was clear even in 2009. mg/mL) for liquid parenteral drug products.

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Drug Target Review

OCTOBER 30, 2024

In light of the natural composition of organs, a formal definition of an ‘organoid’ might be a mini organ in a dish that comprises all or most of the various cell types found in the organ being modelled. Kidney repair is one area of urgent need. Once damaged, kidneys do not regenerate or repair on their own.

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Cytel

APRIL 22, 2024

Adler, Director, Global Product Engagement, and J. Each definition of probability of success has benefits and limitations both in the way it is measured, and the way it is accounted for in study design and execution. Written by Boaz N.

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

Both Durveqtix and Adzynma were major advancements this year, as well as the EMA granting PRIME designation for Ultragenyx’s Angelman syndrome, Sangamo’s Fabry disease, and Spur’s Gaucher disease products. Both approaches need experts in the drug process, and CROs can definitely make an impact. DA: Several things!

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The Pharma Data

JULY 2, 2025

Timeline of the Transaction The acquisition process began on May 16, 2025, when BioMarin and Inozyme jointly announced the signing of a definitive merger agreement. By incorporating Inozyme’s scientific platform and lead asset into its portfolio, BioMarin aims to accelerate the path to regulatory approval and eventual commercialization.

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Perficient: Drug Development

NOVEMBER 14, 2023

Effective consent solutions stem from upfront strategy definition and a clear understanding of each client’s unique regulatory, technology, and policy landscape. Production operation strategy, business workflow design and implementation: Developing strategies and workflows for efficient consent management in production.

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PPD

MARCH 11, 2025

While there is no universally accepted definition for rare disease, it is estimated that more than 10,000 distinct rare conditions exist, and people living with these rare diseases represent as much as 10% of the global population.

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Cytel

MARCH 20, 2024

1 The draft is currently open for public consultation until April 2, and feedback received will be considered before the European Commission finalizes the Implementation Act.

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Perficient: Drug Development

JANUARY 30, 2025

What to Do Now This is a definite leap forward and progress in the direction of what we have long said is the destinationmore and smaller models targeted at specific use cases. For now, when looking at our clients, we advise a healthy dose of wait and see.

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FDA Law Blog: Biosimilars

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. 50,036 (Aug. DASCA became law, amending the CSA, on December 18, 2014.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. The scope of the QMSR is “unchanged” from the QS Regulations, which applies to finished devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated as devices. FDA further retained some definitions in the QSMR.

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Drug Target Review

APRIL 14, 2025

By definition, preventative drugs are taken by a larger number of customers because you never know exactly whos going to get an infection its probabilistic. We had to build intellectual property strategies around a production organism thats relatively unfamiliar in biotech, requiring new types of patents and trade secrets, he says.

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Perficient: Drug Development

AUGUST 21, 2023

Instead of the “all-in-one” approach of Sitecore XP, XM Cloud , and Headless encourage a composable architecture – one where Sitecore itself offers 11 SaaS products categorized into three clouds : Content Cloud, Engagement Cloud, and Commerce Cloud. What is a Composable Architecture?

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The Premier Consulting Blog

MAY 4, 2023

Given this trend, many biopharmaceutical companies are investing in strategies to develop and commercialize new or existing ophthalmic products that address unmet medical needs. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product.

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LifeSciVC

APRIL 17, 2025

In building the target product profile (TPP) for these, consider what makes the mechanism uniquely suited to address unmet needs in a given disease, and objectively map out what would be base, low, and high cases for the program in the context of the competitive landscape (see Fig. 1 for an exemplary framework).

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DrugBaron

JANUARY 31, 2024

Consider target selection, which is probably the most critical decision for any drug R&D project (after all, if the target is wrong, then everything that follows will by definition be wasted). Want to know if your AI-identified tweaks to the productivity of your chemical plant do indeed improve output?

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LifeSciVC

SEPTEMBER 4, 2024

When time is limited, it’s important to set up these seed-planting meetings to be productive. There is definitely a time for process, but especially early on, those that work with me hear “keep it simple“ several times a day. Starting a conversation How you spend your time building your enterprise is as personal decision as any.

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Perficient: Drug Development

FEBRUARY 6, 2024

Achievements: Sunset Microsoft NAV Transformed and converted Inventory Items from NAV to Oracle Fusion Streamlined the manufacturing process and created Item Structures and Work Definitions and migrated to Oracle Fusion cloud Implemented Oracle Procure to Pay solution in support of Caldera’s business process Created Industry specific custom Accounts (..)

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Molecular Design

DECEMBER 31, 2024

Derek has already posted on the H2024 study which been included in the BL2024 Virtual Special Issue on natural products (NPs) in medicinal chemistry. A more permissive definition of activity would generally be expected to make SAR appear to be less tight (or looser if you prefer).

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FDA Law Blog: Biosimilars

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. This particular federal legislative effort, however, continues the debate.

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Perficient: Drug Development

FEBRUARY 13, 2025

SAP Business Data Cloud I don’t know much about SAP, so you can definitely learn more here. I don’t want to get ahead of myself, but I would definitely consider putting that other instance of Databricks on another hyperscaler. In both directions. With governance. This is big.

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