In-Vitro Marketing Reagent Regulation 
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. This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2.
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
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. I look forward to updating the market when we have definitive clinical performance data.”. 28, 2021 09:19 UTC. Source link.
Drug Discovery World
FEBRUARY 15, 2023
However, over the last few decades, it has been widely accepted that interaction between the tumour and host immune response plays a critical role in regulating tumour biology and hence its progression. The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019.
Drug Discovery World
MAY 16, 2023
What opportunities and challenges are emerging and can therapies get to market faster? Moreover, he says that global supply chain pressures will continue into 2023, combined with instability in the financial markets that will make cost of goods high on his watchlist of risks to manage. DDW’s Megan Thomas finds out.
FDA Law Blog
AUGUST 3, 2022
Thirty years ago today, FDA announced that it had the authority to regulate you. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. By Jeffrey N. Gibbs & Allyson B. Mullen — Happy Birthday Laboratory Developed Tests (LDTs).
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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