The Pharma Data

MARCH 23, 2022

We are also donating reagents and consumables for automatic testing of up to 120,000 blood donations and 31,000 units for diabetes management. We are doing everything necessary to safeguard and support our employees and their families whilst also ensuring global supplies of our products. Source link: [link].

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The Pharma Data

MARCH 17, 2021

Through automation of manual tasks, Roche’s new solution is designed to simplify workflows and improve the productivity of lab personnel whilst also supporting the delivery of better patient care. Standardisation enables labs to do more work on fewer instruments, through consolidation of workflows, systems and reagents.

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. There is much to unpack, and we intend to do so in a series of blog posts.

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Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.

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Protein In-Vitro Production Reagent 52

FDA Law Blog

MARCH 16, 2023

The authorization of this De Novo, with a formal classification of Class II, now opens the door for follow-up 510(k) submissions that declare this product as their predicate. We are not aware of any other microbiological in vitro diagnostic test that contains the word “simple” in the regulation.

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FDA Law Blog

APRIL 19, 2021

FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

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The Pharma Data

MARCH 16, 2022

3, and Delta ([link] About TIB Molbiol TIB Molbiol is a subsidiary of Roche Diagnostics that has supplied the global market with reagents for research and medical diagnostics for over 30 years. Roche and its subsidiary, Tib Molbiol, confirm that it has tests for research use that identify the SARS-CoV-2 subvariants of concern, Omicron: BA.1,

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Roots Analysis

OCTOBER 16, 2023

These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. The process of DNA cloning / gene cloning needs to be monitored closely to ensure high-quality and stable finished product. There are some motifs, such as hairpin loops which hinder the usability of a gene.

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DNA Gene Protein In-Vitro 40

XTalks

OCTOBER 1, 2020

Leaving academia for industry is a route that academic scientists and professors did not traditionally pursue in the past due to perceived differences in skillsets, experiences and even associated stigmas. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments.

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Scientist In-Vitro Research Life Science 52

XTalks

JANUARY 6, 2025

Medical device manufacturers are leveraging these technologies to enhance their products, supporting healthcare providers and improving patient outcomes. Read on to explore the innovations shaping the biotech landscape and gain a glimpse into the exciting developments on the horizon for 2025 and beyond.

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Gene Therapy RNA Gene Editing Gene 111

FDA Law Blog

FEBRUARY 23, 2025

FDA stated that several of the companys products required a new 510(k) due to smaller diameter shafts, smaller diameter lumens, smaller tip elements, and/or longer shafts than the originally cleared products. By Steven J. Gonzalez & Allyson B. See 21 C.F.R. But this guidance has its limitations.

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