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
MAY 25, 2022
It is not uncommon for some in vitro diagnostic tests to suffer from poor positive predictive value, in part due to the rarity of the disease. Our readers will recall that this report was issued shortly after FDA’s release of its draft guidance documents seeking to regulate laboratory developed tests.
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Drug Discovery World
MARCH 26, 2024
We were excited to unveil data showing that two distinct chemical series exhibit METTL1 inhibition in vitro at low nanomolar concentrations with minimal interference with other RNA and protein methyltransferases. OR: The presentations at ESMO TAT 2024 highlighted our advances in targeted and more personalised anti-tumour therapies.
FDA Law Blog
DECEMBER 13, 2022
Gibbs — It is widely expected that the fate of the VALID Act – and therefore the world of diagnostic regulation – will be determined in the next two weeks (see our previous post here ). Javitt & Jeffrey N. This is not a trivial matter. Telehealth has become increasing important to the health care system. Emphasis added).
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.”
The Pharma Data
JANUARY 27, 2021
Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its state-of-the-art facilities at Eurofins Cerep, DiscoverX and Panlabs. FDA Investigational New Drug (“IND”)-enabling pharmacology studies. About BetterLife Pharma: BetterLife Pharma Inc.
Drug Discovery World
SEPTEMBER 28, 2023
In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. The influence of these microbiomes extends to children as well.
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