FDA Law Blog

MARCH 19, 2024

is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen’s extensive experience and contributions to the field of in vitro diagnostic (IVD) regulation. (HP&M), the largest dedicated food and drug law firm in the U.S.,

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XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. Such precise detection is crucial for accurately pinpointing patients most susceptible to developing severe HDFN.

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The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. A2 anticipates that the successful development of its allogeneic Tmod candidate therapy will enable subsequently developed allogeneic Tmod candidates.

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FDA Law Blog

NOVEMBER 1, 2023

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 ).

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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. The outcome was not a surprise, because the FDCA was designed for regulatory oversight of medical device manufacturing and distribution, not clinical laboratory testing.

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Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Proper planning of PK assessments can accelerate the development of both novel drugs and new formulations of previously approved drugs developed via the 505(b)(2) pathway.

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The Pharma Data

SEPTEMBER 17, 2020

Industry body says in vitro diagnostics are vital to clearing the backlog of undiagnosed conditions. Ahead of the upcoming comprehensive spending review, The British In Vitro Diagnostics Association (BIVDA) has called for more support for the UK in vitro diagnostics (IVD) industry. Source link.

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The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Continuous professional development. The results demonstrate that regulatory knowledge and qualifications are an advantage and of value in personal and professional development.

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BioTech 365

OCTOBER 6, 2020

Developed by Resolution Medical, an in vitro diagnostic and medical device manufacturer, the innovative 3D-printed sterile swab is … Continue reading →

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Roots Analysis

SEPTEMBER 4, 2024

The main purpose of in vitro diagnostic solutions is to perform non-invasive / minimally invasive test procedures in order to detect a variety of health conditions using samples, such as blood, tissue or urine. Such tests help to diagnose health conditions, monitor treatments, perform disease screening and aid in early diagnosis of diseases.

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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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XTalks

JULY 28, 2020

Using a database developed by Brian Shoichet, PhD, a professor in the Department of Pharmaceutical Chemistry at UCSF, Shoichet and his team worked with Laszlo Urban, PhD, global head of preclinical safety profiling at NIBR, to identify possible interactions between commonly-used excipients and human enzymes and receptors.

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FDA Law Blog

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., By Allyson B. Devices Marketed Under an Enforcement Policy.

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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

JANUARY 18, 2022

Developing Complex, Translatable and Physiologically-Relevant Cellular Models in vitro. Key Benefits of Attending: • Discuss the uses of advanced cell technologies to construct in vitro models of human tissues. Workshop Leader: Kenny Dalgarno, Professor of Manufacturing Engineering, Newcastle University.

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pharmaphorum

OCTOBER 12, 2020

Over the past few years, 3D Cell Culture has gained momentum within the pharmaceutical industry due to the benefits that this model offers for in vitro applications patient-derived tissues, drug discovery, predictivity and validation, and safety and toxicity. Sakshi Garg, Lab Head, Discovery & Development Technologies, Merck Group.

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FDA Law Blog

SEPTEMBER 21, 2022

The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.

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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. This type of public spat does not instill confidence in companies developing or investing in OTC IVDs. In the intervening decades, FDA has cleared approximately 1,200 OTC IVDs.

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FDA Law Blog

MARCH 31, 2024

They believe any regulatory oversight for laboratory developed tests (LDTs) should be mandated by Congress, rather than the Executive Branch. The majority of witnesses, along with several of the Congressional members, agreed that legislation is the appropriate path to regulating laboratory developed tests.

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FDA Law Blog

MAY 17, 2021

You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID?19 At the time, we wrote favorably about this move. Put bluntly, the review of COVID?19

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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. SCF : LDT, unmet need within an integrated healthcare system.

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The Pharma Data

JANUARY 19, 2021

TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is using its pioneering FasTCAR and TruUCAR technology platforms to discover and develop breakthrough cell therapies. Ortho Clinical Diagnostics is a leader in in vitro diagnostics. With this kind of a start, 2021 may be scorching.

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FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). There is much to unpack, and we intend to do so in a series of blog posts. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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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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The Pharma Data

MARCH 23, 2022

About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. Roche remains hopeful the war will reach a peaceful resolution as soon as possible. Source link: [link].

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The Pharma Data

DECEMBER 14, 2020

“The rapid progress we have made to date is a credit to the outstanding research by our teams and university partners, the strength of HBM’s fully human antibody discovery platform and AbbVie’s world leading expertise in antibody and antiviral drug development,” said Dr. . before expanding it into Europe.

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FDA Law Blog

MAY 17, 2021

Shapiro — You may recall that last summer (on August 19), the Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to cease premarket review of laboratory developed tests (LDTs), including COVID?19 At the time, we wrote favorably about this move. Put bluntly, the review of COVID?19

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pharmaphorum

AUGUST 24, 2020

The conference is proudly chaired by Lynne Ensor, Vice President, Technical, Parexel International as a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. in Biology and Ph.D.

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The Pharma Data

DECEMBER 20, 2020

. PARTNERSHIP LEVERAGES COMPLEMENTARY STRENGTHS OF IN SILICO, IN VITRO AND IN VIVO ANTIBODY DISCOVERY IN A RANGE OF INDICATIONS. ” ABOUT ALLOY THERAPEUTICS Alloy Therapeutics is a biotechnology company dedicated to empowering scientists in the relentless pursuit of making better medicines for all.

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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.

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The Pharma Data

MARCH 3, 2022

About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced an initial donation of essential medicines to Ukraine.

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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? Companies should ensure key words are appropriate and do not constitute unauthorised promotion to the public.

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XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. 1) Medtronic 2022 Revenue: Medtronic reported an annual revenue of $31.69

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The Pharma Data

DECEMBER 21, 2020

These results suggest that early antiviral treatment of SARS-CoV-2 infection may protect against developing severe COVID-19 lung disease. The trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with galidesivir treatment compared to placebo treatment was observed in the trial.

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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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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics. 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.

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