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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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. General Wellness Products.

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Drug Discovery World

OCTOBER 9, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The post Exclusive event: Scaling up in vitro transcription appeared first on Drug Discovery World (DDW).

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Drug Discovery World

NOVEMBER 2, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The post Scaling up in vitro transcription: Exclusive free event appeared first on Drug Discovery World (DDW).

In-Vitro 52

In-Vitro Reagent DNA Production 52

Drug Discovery World

OCTOBER 2, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The effect of several variables on the IVT reaction using different size DNA templates was assessed.

In-Vitro 52

In-Vitro Reagent DNA Production 52

Drug Discovery World

OCTOBER 16, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The effect of several variables on the IVT reaction using different size DNA templates was assessed.

In-Vitro 52

In-Vitro Reagent DNA Production 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.

Marketing 40

Marketing In-Vitro Regulation Reagent 40

Drug Discovery World

OCTOBER 23, 2023

Join DDW for this exclusive free event, Scaling up in vitro transcription: Key results and considerations , which is supported by Thermo Fisher Scientific. In vitro transcription (IVT) can be a complicated reaction. The post Webinar: Scaling up IVT in mRNA production appeared first on Drug Discovery World (DDW).

Production 52

Production In-Vitro Reagent DNA 52

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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Drug Discovery World

OCTOBER 13, 2022

Another productive panel included Science Solutions Recruitment – Futureproof your career in Drug Discovery , featuring Paul Mears from Science Solutions Recruitment and Andrew Ratcliffe from Domainex. . Over the two days at ExCel, 1554 delegates attended the event. Of those delegates, 75% work in drug discovery. From the floor .

Drugs 52

Drugs In-Vivo In-Vitro Biobanking 52

Drug Discovery World

MAY 16, 2023

The deeper the understanding of product and process from a characterisation standpoint, the smoother the regulatory conversations and development pathway will be.” What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster? DDW’s Megan Thomas finds out.

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Gene Therapy Gene Manufacturing Marketing 52

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,

In-Vitro 52

In-Vitro Genotype Reagent Protein 52

FDA Law Blog

AUGUST 3, 2022

Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug.

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XTalks

JULY 13, 2022

The Minuteful Kidney test kit is delivered to the patient’s home and is made up of all these things needed for in vitro home ACR testing: A urine collection cup. An ACR urine reagent dipstick/strip. An absorbent pad to remove excess liquid from the reagent strip. Healthy.io Healthy.io

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Reagent In-Vitro Radiology Life Science 98

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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In-Vitro Regulation Production Compliance 64

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

JANUARY 27, 2021

Avacta has worked with Adeptrix Inc (Beverly, MA, USA) to develop a coronavirus antigen test that combines enrichment of the sample using Affimer® reagents with the analytical power of mass-spectrometry. 28, 2021 09:19 UTC. CAMBRIDGE & WETHERBY, England & BILLERICA, Mass.–(

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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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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.

Reagent 52

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Drug Discovery World

FEBRUARY 15, 2023

Sophisticated and continually evolving preclinical IO models (in vivo and in vitro) are particularly helpful in defining translational therapeutic strategies and understanding the efficacy of combination immunotherapies and refractory cancers, and in the identification of novel prognostic biomarkers. This continues to be the standard of care.

Research 52

Research In-Vitro In-Vivo Development 52

Drug Discovery World

FEBRUARY 27, 2023

PerkinElmer targets screening methods End-to-end solutions provider PerkinElmer launched two new products at the show targeting both high high-throughput screening (HTS) applications and next-generation screening (NGS). Here are some of the biggest launches that were on offer throughout day one of the show.

Drugs 52

Drugs Life Science Protein Scientist 52

Drug Discovery World

OCTOBER 14, 2022

Reducing assay volumes from about 200 µL to 1 µL ha s cut the quantities of reagents and consumables needed, while automation has replaced manual handling, so lowering running and personnel costs. . The rapid evolution of HTS to meet industry demand . Overcoming challenges in HTS using mass spectrometry .

Drugs 52

Drugs In-Vitro Development Production 52

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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