XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. But to meet aggressive milestones and stringent performance standards, there’s a need for continuous innovation and streamlined development and quality control workflows.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. These products will require clinical trial data to get to market, but with significantly fewer participants required as compared to a drug trial.

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Clinical Trials Clinical Trials Trials Production 52

Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., They can be essential for selecting appropriate participants, identifying potential adverse reactions, and studying how a drug affects the human body. IVDs are used in almost all clinical research. IVDs are used in almost all clinical research.

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Drug Discovery World

FEBRUARY 27, 2023

The company launched its EnVision Nexus system at the show, which is designed for demanding HTS applications and to help accelerate drug discovery efforts. As the company’s first HT system, it has been designed to overcome adoption barriers currently limiting the use of predictive human liver models within drug discovery workflows.

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Advarra

SEPTEMBER 23, 2022

The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” . Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. .

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FDA Law Blog

DECEMBER 6, 2023

The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA. The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Javitt — On Monday, Hyman, Phelps & McNamara, P.C. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation.

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The Pharma Data

NOVEMBER 17, 2021

Nasdaq VIR) moment blazoned US government contracts totalling roughly$ 1 billion (1) (USD) to buy sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, which the US Food and Drug Administration (FDA) granted Exigency Use Authorization (EUA) in May 2021. 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

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Antibody In-Vitro Vaccination Vaccine 52

The Pharma Data

JANUARY 16, 2021

It has become the de facto standard equipment for high titer transient protein expression platforms used by many leading Chinese antibody drug pharmaceutical companies and IVD (In Vitro Diagnostics) companies since its launch in Oct. for non-viral cell immunotherapeutic drug development. JS Bio’s parent company.

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Advarra

JULY 18, 2023

Clinical trials involving investigational in vitro diagnostic (IVD) devices are subject to the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) requirements ( 21 CFR 812 ). When an investigational device does not carry this potential for serious risk, the clinical investigation is NSR.

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Research Clinical Trials Clinical Trials Trials 52

The Pharma Data

OCTOBER 27, 2020

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. 3a will continue to advance its industrial design, product usability, labelling compliance, regulatory approval, and production planning work in parallel to its validation studies. .”

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Drug Discovery World

APRIL 3, 2023

As the industry moves to reduce the use of animals in research and testing, aptamers also support here, as they are discovered, developed, and manufactured entirely in vitro , removing the need for animals in antibody discovery processes. DDW’s Diana Spencer caught up with co-founder and CEO Dr Arron Tolley.

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The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .

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Advarra

AUGUST 31, 2022

If a new medical device, software as a medical device (SaMD), or in vitro diagnostic (IVD) is poised to successfully make it through the development process to commercialization, sponsors must consider a trifecta of interconnected systems involving: Regulatory strategy and submissions. Quality assurance and risk management. Intended use.

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Research Regulation Clinical Trials Clinical Trials 52

FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. These products are subject to the same regulatory requirements as any unapproved medical device”).

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In-Vitro Regulation Compliance Production 98

The Pharma Data

NOVEMBER 4, 2020

CENTOGENE’s SARS-CoV-2 test is a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from presymptomatic patients and probands according to the recommended testing by public health authority guidelines. CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Nov.

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Drug Discovery World

MAY 16, 2023

He continues: “ISCT has also embraced the opportunity to foster collaboration among the CGT community to enable successful process development and regulatory compliance. What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster?

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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XTalks

JUNE 12, 2023

The US Food and Drug Administration (FDA) granted approval to four of Medtronic’s cardiovascular product offerings, further expanding the company’s foothold in this sector. This article takes a comprehensive look at the top 10 medical device companies that are leading the charge in this rapidly evolving field.

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Pharmaceutical Technology

NOVEMBER 22, 2022

mRNA vaccines can be made more quickly than traditional vaccine platforms because they are produced using an in vitro synthetic process that does not require the time-consuming growth or removal of cells and proteins. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. The UK Government is behind this effort.

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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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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

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pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criterion 1. Criterion 2.

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FDA Law Blog

FEBRUARY 4, 2024

Medical Device Reporting, Quality System Regulation compliance, and reporting of corrections and removals). The joint press release largely repeats, and has CMS endorse, the arguments FDA has previously made in support of its proposed rule, which we rebut in the detailed comments we filed on behalf of a coalition of laboratories.

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Regulation Radiology Cosmetics Compliance 59

Roots Analysis

OCTOBER 19, 2023

The overuse of antibiotics has resulted in the emergence of multi-drug-resistant bacteria. Bacteria plays a crucial role in maintaining the ecosystem balance. However, there are few species of bacteria that can cause several infectious diseases ( such as strep throat, salmonellosis, tuberculosis, whooping cough ).

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FDA Law Blog

OCTOBER 10, 2022

As a refresher, the Cures Act established the following four criteria for Non-Device CDS software: Criterion 1 : Non-Device CDS software functions do not acquire, process, or analyze medical images, signals from an in vitro diagnostic (IVD) device, or patterns or signals from a signal acquisition system.

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