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. This latest donation demonstrates our commitment to meeting the need for Roche medicines and diagnostics in Ukraine whenever possible. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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The Pharma Data

DECEMBER 14, 2020

Description of the problem : WHO has received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using RT-PCR reagents on open systems. . In the early phases of the COVID-19 pandemic, in vitro diagnostics (IVDs) were rapidly developed, validated and verified, and then rolled out.

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pharmaphorum

SEPTEMBER 29, 2022

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. When assessing mHealth technology, the FDA will determine whether an application is either: i.

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XTalks

APRIL 22, 2022

Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. What is Flow Cytometry?

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The Pharma Data

MARCH 17, 2021

Standardisation enables labs to do more work on fewer instruments, through consolidation of workflows, systems and reagents. cobas® pure integrated solutions brings together three diagnostic technologies 1 on a single platform to optimise space and resources in small to medium laboratory settings.

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FDA Law Blog

SEPTEMBER 21, 2022

This policy and the EUA templates mirror the approach taken by FDA for COVID-19. With COVID-19, CDRH was forced to “build the plane while flying it,” in that it had to create the administrative infrastructure and related guidance and templates while simultaneously issuing the first round of EUAs. The policy also addresses serology tests.

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In-Vitro Development Reagent Manufacturing 52

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

MARCH 16, 2023

We are not aware of any other microbiological in vitro diagnostic test that contains the word “simple” in the regulation. a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis.

Marketing 40

Marketing In-Vitro Regulation Reagent 40

FDA Law Blog

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Add one more to that tally. Genus Medical Technologies secured an important victory in the D.C. Circuit Court of Appeals on Friday. In Genus Medical Technologies v. Two judges on the D.C.

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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.

Scientist 52

Scientist In-Vitro Research Life Science 52

FDA Law Blog

AUGUST 3, 2022

Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug.

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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. DNA and Gene Cloning involves the isolation of a DNA sequence of any species ( often a gene ) and its insertion into a vector to enable growth without any alteration in the original DNA sequence.

DNA 40

DNA Gene Protein In-Vitro 40

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.

Protein 52

Protein In-Vitro Reagent Production 52

The Pharma Data

AUGUST 4, 2020

This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories.

DNA 52

DNA In-Vitro Medicine Reagent 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

XTalks

JUNE 27, 2022

CerTest Biotec specializes in the development and manufacturing of in vitro diagnostic medical devices and has expertise in the detection of human diseases. In a joint press release , the companies said the aim of the partnership is to design a diagnostic test that can help advance understanding of the global spread of the disease.

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Development In-Vitro Reagent Vaccine 83

The Pharma Data

SEPTEMBER 7, 2020

The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications.

In-Vitro 52

In-Vitro Medicine Reagent DNA 52

FDA Law Blog

FEBRUARY 23, 2025

By Steven J. Gonzalez & Allyson B. Mullen As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. See 21 C.F.R. But this guidance has its limitations.

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XTalks

JANUARY 6, 2025

In recent years, CRISPR has also been effectively applied to reduce or eliminate persistent viral infections in vitro and in animal models, raising hope for its use in treating latent and chronic viral infections. Related: Biotech IPOs in 2024: Navigating the New Wave of Innovation 1.

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