In-Vitro Manufacturing Reagent Regulation 
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.
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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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. . Manufacturers regularly review the design of their product, including labelling and IFU based on customer feedback.
Drug Discovery World
MAY 16, 2023
Curbishley explains that as the wave of new therapies in development continues to increase, global pressures on manufacturing availability will become more acute. 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.
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.
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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