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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Pfizer

JANUARY 27, 2023

This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 70 countries to treat COVID-19.

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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 Our readers will recall that this report was issued shortly after FDA’s release of its draft guidance documents seeking to regulate laboratory developed tests.

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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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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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XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. Sartorius understands the need for continuous innovation in the highly regulated and price-sensitive diagnostics market. Xu joined Sartorius in 2002.

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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. Coloplast’s product portfolio includes Ostomy Care, Continence Care, Wound and Skin Care, Interventional Urology and Voice and Respiratory Care.

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pharmaphorum

OCTOBER 27, 2022

The Guidance applies to both product-related and therapeutic-area-related activities. 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?

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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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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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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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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? . 21 CFR 312.40(a)

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Roots Analysis

JANUARY 14, 2024

Overview of Biologics Biologics refer to medicinal / therapeutic products that are either manufactured using living organisms or semi-synthesized from biological sources. Like all drugs, biologics are regulated by the FDA. This can be attributed to the fact that the production of biopharmaceuticals requires living expression systems.

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Drug Discovery World

MAY 16, 2023

What opportunities and challenges are emerging and can therapies get to market faster? The deeper the understanding of product and process from a characterisation standpoint, the smoother the regulatory conversations and development pathway will be.” What are the global innovations in cell and gene therapy?

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Drug Discovery World

DECEMBER 8, 2023

It’s true that both general and vertical AI tools can make businesses more efficient but only vertical AI will enable a reduction in costs, improve operational efficiencies and productivity, and produce high-quality cell and gene therapy programs. The cell and gene therapy industry is no exception to this digital transformation.

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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

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. About XPhyto Therapeutics Corp.

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The Pharma Data

JANUARY 16, 2021

Etta Biotech”), to set up a high titer transient protein expression platform for high quality protein production using JS Bio’s transient transfection media. The two parties also plan to join force further to build a rapid protein production platform aiming at producing gram-scale protein for R&D, e. JS Bio’s parent company.

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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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FDA Law Blog

JANUARY 3, 2022

There are multiple explanations for the current inadequate number of tests ( link ), including government policies on test procurement, manufacturers’ decisions to curtail production when demand fell this summer, the extraordinarily rapid spread of the omicron variant, and surges in demand brought on by the holidays.

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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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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. He has in depth Global Development Expertise (e.g. Previously, he held roles as CMO at Trimeris Inc.

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FDA Law Blog

JANUARY 3, 2022

There are multiple explanations for the current inadequate number of tests ( link ), including government policies on test procurement, manufacturers’ decisions to curtail production when demand fell this summer, the extraordinarily rapid spread of the omicron variant, and surges in demand brought on by the holidays.

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FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. Mullen — Happy Birthday Laboratory Developed Tests (LDTs). 92P-0405 (Aug.

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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

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

JANUARY 16, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. Nine participants will be selected to use the non-In Vitro Diagnostic eSTAR. checks for incomplete sections. checks for incomplete sections.

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The Pharma Data

APRIL 28, 2021

Fosmanogepix has demonstrated broad-spectrum activity in-vitro and has shown wide distribution to various tissues including the brain, lung, kidney and eye. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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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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pharmaphorum

OCTOBER 18, 2021

Also worth exploring is the regulatory oversight and approval process for medical devices and in-vitro diagnostics (IVDs). In contrast to the evaluation of medicines, the supervisory framework for medical devices and IVDs is fragmented and there is no single ‘go-to’ authority, which can be problematic for some products.

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FDA Law Blog

FEBRUARY 2, 2024

Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). By Steven J. Gonzalez & Allyson B.

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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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The Pharma Data

AUGUST 18, 2020

following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S. REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. and around the world.

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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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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. PXL770 is a first-in-class, oral direct adenosine monophosphate-activated protein kinase (AMPK) activator. .

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XTalks

JUNE 12, 2023

In Medtronic’s annual report, CEO Geoff Martha attributes their success in this area to their comprehensive suite of products and solutions, which equip clinicians with the tools necessary for optimal atrial fibrillation care. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

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Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. It is important to note that these studies are required by U.S. and around the world.

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