FDA Law Blog

JUNE 14, 2021

Shapiro — In our last post on Laboratory Developed Tests (LDTs) , we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. This step would help propel forward a public conversation (which CMS has already started ) about how to update these regulations in light of technological advances.

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FDA Law Blog

SEPTEMBER 29, 2023

Today, FDA released a copy of a proposed rule to regulate laboratory-developed tests (LDTs), which is scheduled to be published in the Federal Register on October 3rd. For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

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FDA Law Blog

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. While at FDA, Ms. During her FDA tenure, Ms. Gibbs , HP&M Director.

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Drug Discovery World

SEPTEMBER 1, 2022

Bio-Rad Laboratories has introduced a range of type 1 antibodies that inhibit the binding of evolocumab (Repatha) to its target, human proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that has been shown to play a key role in the regulation of cholesterol levels. .

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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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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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pharmaphorum

JANUARY 17, 2022

Under the joint research plan, the Danish giant will work with EraCal to identify novel drug targets relevant for food intake regulation and additional metabolic phenotypes. Central nervous system-controlled behaviour, such as food intake, is notoriously difficult to explore in vitro.

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Pharmaceutical Technology

JULY 15, 2022

Despite entering its fourth decade of availability, in vitro fertilization (IVF), a medical technique used to facilitate the conception of a baby for those facing fertility problems, remains an elusive dream for many. Doing so will be vital in slowing the pace at which populations are ageing. Ageing populations increase the need to breed.

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Drug Discovery World

JANUARY 17, 2024

This anchoring regulates metabolism and mitochondrial morphology. This pathway is essential for cell communication and regulates multiple cell processes, including cell proliferation, differentiation and programmed death. The results were consistent with the in vitro experiments.

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pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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XTalks

DECEMBER 28, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.

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ProRelix Research

JUNE 26, 2023

As per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, […] The post US FDA Medical Device Applications appeared first on ProRelix Research.

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Pharma Business Blog

FEBRUARY 7, 2023

A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR) 1 and (EU) 2017/746 (IVDR) 2. – The extension is directly applicable, therefore changing the date on the individual certificates is not necessary.

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Drug Discovery World

MARCH 19, 2024

My research is focused on developing a 3D in vitro model of adipose tissue which can be used in the lab to help us better understand the complex signalling pathways of metabolic disorders and hopefully allow the discovery of better, curative treatments. DS: What’s been the highlight of your career so far? The environment in eg.

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FDA Law Blog

MARCH 3, 2024

Mullen — FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards being finalized – and to a likely judicial showdown. This stands in marked contrast to FDA’s prior efforts to regulate LDTs (see posts here , here , and here ). By Jeffrey N. Gibbs & Allyson B.

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FDA Law Blog

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. For 510(k) and De Novo submissions, FDA’s eSTAR Program website offers two different types of eSTAR templates: Non-In Vitro Diagnostic devices and In Vitro Diagnostic devices.

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Scienmag

OCTOBER 18, 2020

18, 2020) – Success rates for in vitro fertilization are higher at clinics that voluntarily share more information than required by government regulators, according to new research by faculty at the University of Colorado School of Medicine. AURORA, Colo.

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Drug Discovery World

OCTOBER 2, 2023

Karikó and Weissman noticed that dendritic cells recognise in vitro transcribed mRNA as a foreign substance, which leads to their activation and the release of inflammatory signalling molecules. The effect was due to the reduced activation of an enzyme that regulates protein production.

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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.

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FDA Law Blog

SEPTEMBER 27, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements.

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Drug Discovery World

MARCH 8, 2023

Dosing has begun in a Phase I clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumours.

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Drug Discovery World

JUNE 19, 2023

Anoat will use the funds to conduct additional in vivo and in vitro pharmacology assessments and select a lead candidate. AdBio Partners’ mission is to support founding scientists in the development of new therapeutic approaches,” said Alain Huriez, Managing Partner of AdBio Partners.

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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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Drug Discovery World

JANUARY 23, 2023

Ubiquigent is supporting a Master’s student at the University of Glasgow (UoG) to undertake a research project on USP30, a (de)ubiquitylation (DUB) implicated in neurodegenerative, renal, and cardiovascular diseases. Overseen by Professor Helen Walden, UoG, and Dr Mehmet Gundogdu, Principal Scientist at Ubiquigent, the project aims to combine biochemistry, (..)

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FDA Law Blog

NOVEMBER 28, 2023

The notice ( here ) indicates that FDA plans for the panel to “discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of MCD screening tests.”

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Drug Discovery World

JANUARY 23, 2023

They showed that diacylglycerol kinase B (DGKB), a regulator of the intracellular level of diacylglycerol (DAG), was significantly suppressed in radioresistant GBM cells. Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care.

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FDA Law Blog

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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XTalks

DECEMBER 14, 2023

XTALKS WEBINAR: Impacts of the New IVD Regulation (IVDR) for Manufacturers and Users Live and On-Demand: Tuesday, January 9, 2024, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how the new In Vitro Diagnostic Regulation (IVDR) impacts manufacturers and users of diagnostic devices.

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FDA Law Blog

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy test clearance in 1978.

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FDA Law Blog

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

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pharmaphorum

SEPTEMBER 22, 2021

The software – called Paige Prostate – is the first artificial intelligence-based to be approved by the FDA for this purpose, according to the US regulator. Software that can help pathologists detect prostate cancer from slides of biopsies more effectively has been approved by the FDA. That compared to 90.9%

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FDA Law Blog

APRIL 24, 2024

The meetings have presented a mix of views with some organizations meeting with OMB being in favor of FDA regulation and others being very much opposed. The final rule was identified by OMB as Section 3(f)(1) significant meaning that the rule “may have an annual effect on the economy of $200 million or more. ;

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Drug Discovery World

SEPTEMBER 28, 2023

Earlier this year, we explored the microbiome and its role in drug development across various therapeutic areas. This article will focus on one such area of great unmet need and promise: women’s health. This is likely in part because their byproduct, lactic acid, is known to inhibit pathogenic bacteria 25.

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The Pharma Data

APRIL 7, 2021

today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. p53 is protein which, when active, helps to regulate processes which stop tumors from developing. p53 is protein which, when active, helps to regulate processes which stop tumors from developing.

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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. Meeting with the Regulators. Intended use.

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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).

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