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.

In-Vitro 59

In-Vitro Manufacturing Antibody Regulation 59

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.

Regulation 40

Regulation Production Drugs In-Vitro 40

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.

Regulation 52

Regulation In-Vitro Manufacturing Life Science 52

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.

In-Vitro 59

In-Vitro Manufacturing Regulation Drugs 59

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.

In-Vitro 52

In-Vitro Regulation Manufacturing Radiology 52

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.

In-Vitro 52

In-Vitro Manufacturing Production Antibody 52

pharmaphorum

AUGUST 10, 2020

The filing with the FDA follows approval by several regulators across the world, including in the European Union and Japan. Originally intended as a treatment for Ebola virus, Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against several emerging viruses.

Drugs 99

Drugs In-Vivo Contract Manufacturing In-Vitro 99

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.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Protein Bacteria 40

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.

In-Vitro 72

In-Vitro Containment Manufacturing Regulation 72

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.

Development 83

Development In-Vitro Reagent Vaccination 83

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. .”

Vaccination 105

Vaccination Vaccine Development Life Science 105

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 .

Clinical Trials 52

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.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

Drug Discovery World

DECEMBER 8, 2023

These therapeutics are complex and one of the major bottlenecks in their development is avoiding downstream impurities during manufacturing, which can cause major safety concerns. Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

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 Regulation Manufacturing Development 52

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.

Life Science 98

Life Science Compliance Regulation Cosmetics 98

Drug Discovery World

MAY 16, 2023

Curbishley explains that as the wave of new therapies in development continues to increase, global pressures on manufacturing availability will become more acute. What are the global innovations in cell and gene therapy? What opportunities and challenges are emerging and can therapies get to market faster? DDW’s Megan Thomas finds out.

Gene Therapy 52

Gene Therapy Gene Manufacturing Marketing 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.

In-Vitro 52

In-Vitro Manufacturing Regulation Development 52

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.”.

Vaccination 122

Vaccination Vaccine Life Science In-Vitro 122

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.

Reagent 52

Reagent In-Vitro Production Regulation 52

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. . .

Development 52

Development Contamination In-Vitro Production 52

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

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.

Marketing 97

Marketing In-Vitro Regulation Manufacturing 97

FDA Law Blog

AUGUST 3, 2022

Thirty years ago today, FDA announced that it had the authority to regulate you. Food and Drug Administration, Compliance Policy Guide, Commercialization of Unapproved In Vitro Diagnostic Devices Labeled for Research and Investigation (Aug. By Jeffrey N. Gibbs & Allyson B. Mullen — Happy Birthday Laboratory Developed Tests (LDTs).

In-Vitro 98

In-Vitro Regulation Compliance Production 98

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.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

JANUARY 16, 2021

It has become the de facto standard equipment for high titer transient protein expression platforms used by many leading Chinese antibody drug pharmaceutical companies and IVD (In Vitro Diagnostics) companies since its launch in Oct. Etta Biotech is a leading cell electroporation technology and equipment supplier. JS Bio’s parent company.

Protein 52

Protein Production Antibody In-Vitro 52

The Pharma Data

MAY 17, 2023

BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Roche’s Chief Medical Officer and Head of Global Product Development.

FDA Approval 40

FDA Approval In-Vitro Trials Clinical Trials 40

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.

In-Vitro 69

In-Vitro Regulation Production Development 69

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death. About Ronapreve (casirivimab and imdevimab).

Antibody 52

Antibody Medicine Production In-Vitro 52

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.

Marketing 75

Marketing Production Drugs Licensing 75

The Pharma Data

DECEMBER 9, 2020

OHMX.bio – Belgium-based OHMX.bio and Fujirebio Europe were awarded a €720,000 research grant from Flanders Innovation & Entrepreneurship (VLAIO) to develop a clinical in vitro diagnostics (IVD) platform incorporating third generation sequencing (TGS) technologies. A solution could be at hand with Overland Pharmaceuticals.

In-Vivo 52

In-Vivo In-Vitro Antibody Development 52

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.

Clinical Trials 40

Clinical Trials Clinical Trials Containment In-Vitro 40

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.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

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.

Research 52

Research Regulation Clinical Trials Clinical Trials 52

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. .

Trials 52

Trials In-Vitro Insulin Protein 52

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.

Drugs 110

Drugs Licensing Licensing Production 110

Roots Analysis

OCTOBER 16, 2023

These clones can be manipulated and mutated in vitro to alter the expression and function of a protein. DNA cloning is a largely accepted technique, however, it has been regulated carefully. There are some motifs, such as hairpin loops which hinder the usability of a gene.

DNA 40

DNA Gene Protein In-Vitro 40