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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Trials Clinical Trials Clinical Trials Antibody 97

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

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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In-Vitro Manufacturing Antibody Regulation 59

pharmaphorum

MARCH 4, 2021

The guidance comes from the ACCESS Consortium of regulators from the UK, Australia, Canada, Singapore and Switzerland. ” BIVDA, the trade association for British in-vitro diagnostic companies, supported the “super-deduction” policy. .”

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Vaccine Vaccination Development Life Science 105

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

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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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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Regulation In-Vitro Manufacturing Life Science 52

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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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. §

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Compliance Manufacturing Regulation In-Vitro 64

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

DECEMBER 16, 2020

We’ve got so many great life science assets in the UK, but there are still some gaps – manufacturing capacity being one of them.”. “We There have also been many pragmatic collaborations between companies, sites and regulators that have helped keep research and HTA going – such as the more flexible rules introduced by the MHRA.”.

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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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Regulation Manufacturing Production Compliance 64

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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Development In-Vitro Reagent Vaccination 83

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.

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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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In-Vitro Manufacturing Regulation Drugs 59

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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In-Vitro Regulation Production Development 69

pharmaphorum

OCTOBER 27, 2022

These risks have resulted in many companies being found in breach of self-regulatory codes, and a view that an increasingly narrow interpretation was being taken by authorities. What is the scope of the Guidance? Information on social media and digital channels should be kept up to date and date stamped, with the date posted or last updated.

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Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

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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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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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Research Regulation Clinical Trials Clinical Trials 52

XTalks

DECEMBER 14, 2023

We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips. Addressing these safety concerns remains a top priority for the FDA.” It is used at home and in clinical settings. In case any issue is detected, the machine should not be used.

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XTalks

SEPTEMBER 20, 2024

Vittoria’s investigational CAR-T therapy leverages gene editing to modulate the CD5 signaling pathway and a shorter manufacturing time to enhance efficacy and improve manufacturing efficiencies and vein-to-vein time. Such challenges highlight a significant unmet need and call for further advancements in the field.

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Advarra

SEPTEMBER 23, 2022

Whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.” . 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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Clinical Trials Clinical Trials Trials Regulation 52

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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Research Regulation Clinical Trials Clinical Trials 52

FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. This article ( link ), which is made available with the permission of the Food and Drug Law Institute, examines multiple facets of FDA’s regulation of COVID assays. The onset of COVID brought unprecedented challenges to FDA.

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In-Vitro Regulation Manufacturing Development 52

The Pharma Data

DECEMBER 14, 2020

Manufacturers regularly review the design of their product, including labelling and IFU based on customer feedback. In the early phases of the COVID-19 pandemic, in vitro diagnostics (IVDs) were rapidly developed, validated and verified, and then rolled out. Check the IFU for each incoming consignment to detect any changes to the IFU.

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Reagent In-Vitro Production Regulation 52

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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Development Cosmetics Regulation In-Vitro 52

FDA Law Blog

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We are almost three years into the public health emergency as a result of the COVID-19 pandemic, and still only have 19 rapid antigen tests authorized for at-home use in the United States. That could happen again.

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Pfizer

DECEMBER 13, 2022

Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, The additional 3.7 million treatment courses are planned for delivery by early 2023. . In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S.

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Drugs Licensing Licensing Production 110

FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. This article ( link ), which is made available with the permission of the Food and Drug Law Institute, examines multiple facets of FDA’s regulation of COVID assays. The onset of COVID brought unprecedented challenges to FDA.

In-Vitro 52

In-Vitro Manufacturing Development Regulation 52

Roots Analysis

JANUARY 14, 2024

With the increased interest and gradual shift of investment from small molecule drugs to biologics and the establishment of several biologics manufacturing companies / biologics CMOs, more than 250 biologic therapies and vaccines have been developed, globally. Like all drugs, biologics are regulated by the FDA.

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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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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

AUGUST 18, 2020

The companies will collaborate on developing and manufacturing REGN-COV2. We’re committing our manufacturing expertise and capacity, and our global distribution network to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”. Regeneron will distribute REGN-COV2 in the U.S.

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

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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Development Cosmetics Regulation In-Vitro 40

XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. This article takes a comprehensive look at the top 10 medical device companies that are leading the charge in this rapidly evolving field.

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Pfizer

JANUARY 27, 2023

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. 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.

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