Camargo

FEBRUARY 16, 2021

However, if another sponsor has already obtained ODD for the same drug and condition and a marketing application has been approved, the new sponsor has the added requirement of providing a plausible hypothesis as to why the proposed drug may be clinically superior to the first already marketed drug in order to obtain ODD.

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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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pharmaphorum

OCTOBER 27, 2022

Websites – Companies can use appropriate search engine optimisation (SEO) and marketing tools to ensure that their websites are displayed high on the list of results for relevant key word searches. Why is guidance needed? What is the scope of the Guidance? Companies can sponsor website content if the role of the company is made clear.

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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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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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Delveinsight

JANUARY 18, 2021

The present Angelman syndrome treatment market revolves around the management of symptoms rather than curing the condition. . Several pharmaceutical and biotech companies in the Angelman syndrome market are exploring the novel curative approaches. As a consequence, Ovid halted everything related to OV101 and Angelman syndrome.

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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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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. Taken together, there is the risk of shortages of medical devices on the EU market.

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FDA Law Blog

SEPTEMBER 27, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. An existing monkeypox virus test kit available for POC or home diagnostic use in international markets. The focus of the program is for both molecular and antigen tests that can be used in either point-of-care settings or home use.

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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. This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2.

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Camargo

MARCH 25, 2021

Per the FDA’s guidance on RPDD : In vitro data supporting the mechanism of action of the drug in the disease or in a related disease may suffice for rare pediatric disease designation, whereas that level of data would not generally suffice for orphan-drug designation. Criteria for Rare Pediatric Disease Designation.

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FDA Law Blog

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

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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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BioSpace

JULY 3, 2022

Rather than selling, Novartis could spin Sandoz off into its own separate entity with its own listing on a stock exchange.

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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 ). However, not all LDTs currently on the market would qualify for grandfathering. Javitt & Jeffrey N. Emphasis added).

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. In effect, these documents serve as road signs helping to direct new market entrants. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process.

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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. The assay is now available for all markets accepting the CE Mark. The assay is now available for all markets accepting the CE Mark. said Thomas Schinecker, CEO Roche Diagnostics.

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Advarra

AUGUST 31, 2022

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and emerging biotech companies are facing increasingly complex pathways to successfully bring their innovative ideas to the market. Meeting with the Regulators. Regulators are not your adversaries.

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FDA Law Blog

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. The primary barrier to bringing new antigen tests to market has been FDA’s minimum requirement of 80% sensitivity for authorization. By doing so, FDA has limited the number of tests that have reached the market, thereby reducing available supply and increasing prices.

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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. Eurofins Discovery: Wendy Parenteau, Director Marketing Communications Email: WendyParenteau@EurofinsUS.com.

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XTalks

JANUARY 8, 2021

Statutory standards for premarket approval including de novo marketing authorization and 510(k) clearance are maintained under the program’s guidelines. In vitro diagnostics that monitor and evaluate serious adverse events associated with newly approved drugs may also qualify. Concerns Raised by AdvaMed. More Specifics.

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FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. By Steven J. Gonzalez & Lisa M.

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FDA Law Blog

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations.

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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. Notably, FDA did not grant marketing authorization of an OTC COVID test until June 6, 2023, when Cue Health finally received de novo authorization.

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The Pharma Data

JANUARY 27, 2021

The collaboration with Bruker announced today will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe. I look forward to updating the market when we have definitive clinical performance data.”.

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FDA Law Blog

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. By Adrienne R. The Draft Guidance provides specific examples illustrating the application of each scenario.

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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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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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Advarra

APRIL 19, 2023

In vitro diagnostic (IVD) devices are tests used on human biospecimens (e.g., Additionally, while the Food and Drug Administration (FDA) regulates all IVDs as medical devices, the agency has generally not enforced device regulations for certain IVDs designed, manufactured, and used within a single CLIA-certified laboratory.

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Advarra

SEPTEMBER 23, 2022

Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : . The Food and Drug Administration (FDA) is the federal entity in the U.S. When Does an IND go into Effect? . The IND goes into effect; and .

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FDA Law Blog

MAY 17, 2021

In particular, these members of Congress seem to be requesting that HHS revive a dysfunctional (and probably unconstitutional ) approach to regulation of LDTs. Given this stated concern about test accuracy and validation, why are they only urging FDA to regulate COVID?19 At the time, we wrote favorably about this move. 19 LDTs again.

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XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. The outlook towards sustainability has been rapidly changing in the business landscape as more companies adopt sustainable business practices.

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The Pharma Data

OCTOBER 27, 2020

European market launch of both COVID-19 tests planned for Q1 2021. The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. 25-minute RT-PCR lab test to complement 15-minute rapid test. XPhyto Therapeutics Corp. ON BEHALF OF THE BOARD.

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XTalks

JUNE 12, 2023

As technology continues to revolutionize every sector of our lives, the medical device industry stands at the forefront of this innovation, playing a pivotal role in enhancing patient care, improving diagnostic accuracy and transforming treatment modalities. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014.

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The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Continuous professional development. DiMichele provides valuable information on some of the available programs. . .

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FDA Law Blog

MAY 17, 2021

In particular, these members of Congress seem to be requesting that HHS revive a dysfunctional (and probably unconstitutional ) approach to regulation of LDTs. Given this stated concern about test accuracy and validation, why are they only urging FDA to regulate COVID?19 At the time, we wrote favorably about this move. 19 LDTs again.

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