FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. 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 ). Gaulkin & Jeffrey N.

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Roots Analysis

AUGUST 29, 2023

Cell therapy is the therapeutic approach which involves the injection of healthy cells in the human body, in order to replace the diseased / non-functioning cells to regulate certain functions. Raw materials used for the production of cell therapies include culture media, growth factors, extracellular matrices and reagents.

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XTalks

JANUARY 21, 2025

The tricuspid valve, one of the heart’s four valves, regulates blood flow from the right atrium to the right ventricle, preventing backflow between these chambers. The liquid portion of the blood (serum or plasma) containing antibodies is separated and tested using the Liason Biotrin parvovirus B19 IgG plus test on a Liason XL analyzer.

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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.–( View source version on businesswire.com: [link].

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FDA Law Blog

MARCH 16, 2023

Baumhardt, Senior Medical Device Regulation Expert — On March 8th FDA granted Quidel’s Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.”

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Roots Analysis

OCTOBER 16, 2023

Further, DNA contains some specific patterns of nucleic acid sequences, for instance, transcription factors as DNA binding sites for a regulatory protein, known as motifs. DNA cloning is a largely accepted technique, however, it has been regulated carefully.

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The Pharma Data

MAY 15, 2023

She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company. For more information on the Sandoz Board of Directors, please also see [link] Disclaimer This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.

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