Agency IQ

DECEMBER 11, 2023

Reference Laboratories with publication of the implementing regulation in the Official Journal. The regulation designated laboratories in Germany, Spain and Sweden to test four categories of high-risk diagnostics, though Notified Bodies and affected manufacturers will have until October 1, 2024 to adopt the new processes.

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thought leadership

NOVEMBER 14, 2023

Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs). If implemented, this rule would result in LDTs generally falling under similar enforcement regulations as other in vitro diagnostic (IVD) products, a significant change from existing policy.

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Regulations FDA Laboratories Production 59

Drug Target Review

SEPTEMBER 8, 2023

This receptor, referred to as retinoic acid receptor alpha (RARα), is recognised for its regulation of gene expression within the nucleus. His laboratory plans to use a “systems biochemistry” approach to further study the role of cytoplasmic and nuclear RARα in T cell activation and differentiation.

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Agency IQ

DECEMBER 15, 2023

The 60-day comment period on the FDA’s proposed rule to revamp the way that laboratory developed tests (LDTs) are regulated ended on December 4th, 2023. Based on AgencyIQ’s review of available comments, it’s clear that key stakeholders are generally opposed to the rule for a wide range of significant reasons.

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Laboratories Regulations 59

Agency IQ

JUNE 16, 2023

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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Laboratories FDA Packaging Regulations 52

PPD

OCTOBER 18, 2023

1 With this growth comes increased demands for laboratory services at all steps across the development process. Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money. Stay ahead of the curve with a great GMP/CMC contract laboratory partner.

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FDA Law Blog: Biosimilars

MAY 27, 2024

Jennifer was with the firm from 2011-2017, before leaving for in-house roles at Apple, Abbott Laboratories, and Cognito Therapeutics. At Apple, she led executive-level meetings, including with the Chief Operating Officer, regarding regulatory and legal challenges associated with shipping regulated health features.

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FDA Law Blog: Biosimilars

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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Laboratories FDA Regulations Licensing 81

Broad Institute

OCTOBER 23, 2024

What is special about these synthetically designed elements is that they show remarkable specificity to the target cell type they were designed for," said Ryan Tewhey, an associate professor at The Jackson Laboratory and co-senior author of the work with Steven Reilly of Yale, and Pardis Sabeti of the Broad. Online October 23, 2024.

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Agency IQ

JULY 26, 2024

BY COREY JASEPH, MS, RAC The newly available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations.

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Laboratories Regulations 59

BMG Labtech

DECEMBER 20, 2024

The amounts of critical enzyme molecules and enzyme concentrations for example may be controlled by the regulation of the rate of protein synthesis and degradation as well as the regulation of gene expression. Measurement of bacterial growth based on optical density (OD 600 ) is frequently used in many laboratories.

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Regulations Laboratories Research Production 52

Conversations in Drug Development Trends

DECEMBER 19, 2024

As regulatory frameworks like the General Data Protection Regulation (GDPR) have heightened the emphasis on data privacy and individual rights, Europe is leading the way in terms of privacy and data. In-Vitro Diagnostic Regulation and The FDAs Final Rule The WODC U.S. In-Vitro Diagnostic Regulation and The FDAs Final Rule The WODC U.S.

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Clinical Trials Regulations Drugs Trials 52

Tecan

MAY 4, 2023

By Magali Wolff You could say that the road to in vitro diagnostic medical devices regulation (IVDR) implementation has been rocky. We have read all of the documents, spent hours in meetings and felt our heart stop with every new announcement about the new regulations.

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Laboratories Regulations Compliance Science 52

Agency IQ

JULY 26, 2024

reference laboratories for high-risk diagnostics The newly available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations. Reference Laboratories: E.U. Some news on E.U.

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Laboratories Regulations Virus Production 40

FDA Law Blog: Biosimilars

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. Gonzalez & Lisa M.

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

The announcement also states that FDA expects most future companion diagnostic and infectious disease IVDs would be regulated as class II devices, even if they are novel and require de novo classification. But there are reasons why this move will not lessen FDA’s workload nearly as much as it might seem at first blush.

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Conversations in Drug Development Trends

NOVEMBER 12, 2024

The process, from patient coordination through manufacturing and administration, is intricate, time-sensitive, and highly regulated. Modifying and expanding the cells in a GMP laboratory. Operationalizing these trials requires proactive and flawless management at every stage.

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Therapies Clinical Supply Clinical Trials Trials 72

FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” By Sarah Wicks & Anne K. In FY2023, FDA conducted over 1000 inspections under the BIMO program.

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Agency IQ

DECEMBER 15, 2023

Key stakeholders weigh in on FDA’s Laboratory Developed Test Rule. The 60-day comment period on the FDA’s proposed rule to revamp the way that laboratory developed tests (LDTs) are regulated ended on December 4th, 2023. While the FDA has traditionally regulated diagnostic products as medical devices in the U.S.,

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Laboratories Science FDA Regulations 40

Quanticate

JUNE 13, 2024

The life sciences industry is one of the most rigorously regulated sectors globally, prioritising patient safety during clinical trials and post-marketing phases. All trials must comply with country-specific regulations set by regulatory bodies.

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Clinical Trials Laboratories Regulations Clinical Research 59

Agency IQ

SEPTEMBER 1, 2023

EPA publishes amendments to PCB regulations The Environmental Protection Agency has finalized a suite of regulations related to polychlorinated biphenyls, including extraction, disposal, and cleanup regulations. PCB-specific regulations are codified in the Code of Federal Regulations. a closed system) uses of PCBs.

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Regulations Laboratories Production Government 40

FDA Law Blog: Biosimilars

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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FDA Laboratories Regulations Compliance 59

FDA Law Blog: Biosimilars

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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Laboratories Regulations FDA Disease 59

Agency IQ

APRIL 26, 2024

BY LAURA DIANGELO, MPH A final rule requiring Laboratory Developed Tests (LDTs) to be regulated as medical devices has obtained clearance from the White House’s Office of Information and Regulatory Affairs today, allowing the FDA to publish the regulation as early as this week.

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Laboratories Regulations FDA 59

The Pharma Data

OCTOBER 27, 2020

HYDERABAD, India–( BUSINESS WIRE )– Dr. Reddy’s Laboratories Ltd. About Dr. Reddy’s : Dr. Reddy’s Laboratories Ltd. 28, 2020 10:09 UTC. BSE: 500124, NSE: DRREDDY, NYSE: RDY) today announced that Parag Agarwal will be joining the Company as Chief Financial Officer (Designate) on November 2, 2020.

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FDA Law Blog: Biosimilars

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). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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Laboratories FDA Regulations Production 64

FDA Law Blog: Biosimilars

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. 3] FDA further assumes that these laboratories collectively perform roughly 80,000 LDTs.

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FDA Laboratories Regulations Production 69

FDA Law Blog: Biosimilars

MARCH 3, 2024

Mullen — FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards being finalized – and to a likely judicial showdown. This stands in marked contrast to FDA’s prior efforts to regulate LDTs (see posts here , here , and here ). By Jeffrey N. Gibbs & Allyson B.

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Laboratories FDA Regulations Government 64

thought leadership

SEPTEMBER 26, 2024

On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for the enforcement discretion approach that FDA has previously exercised for LDTs.

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Drug Target Review

MARCH 19, 2024

These genes have a broad range of function including gene regulation particularly in relation to the metabolism of sugars, lipids, and mitochondrial function (among other pathways). Murray has used his expertise in bioinformatics to establish an internationally recognised laboratory specialising in complex trait genomics.

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Laboratories Bioinformatics International Research Laboratories 106

Drug Target Review

JANUARY 2, 2024

In research published in Scientific Reports , 1 investigators focused on mesenchymal stem cells (MSCs), known for their potential in treating cell defects and regulating immune responses. The experiment comprised two components: computational methodology development and laboratory experiments.

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RNA Immune Response Therapies Disease 128

Elrig

MARCH 25, 2025

After PhD and postdoctoral work in the UK and Singapore, Prof Johnson received a prestigious Ramn y Cajal fellowship at the Centre for Genomic Regulation (Barcelona). There, he worked with the GENCODE consortium to establish foundational lncRNA gene annotations, which are considered a standard reference in the field.

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RNA Bioinformatics Pharmacokinetics Science 59

Alta Sciences

NOVEMBER 4, 2024

With airlocks around the manufacturing and laboratory areas, staff could safely gown and de-gown. Product Disposal: We disposed of all waste and material generated from the manufacturing loteprednol etabonate at regulated chemical treatment facilities.

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Engineering Production Compliance Laboratories 52

ASPET

MARCH 20, 2024

DNA topoisomerase IIβ (TOP2β/180; 180 kDa) is a nuclear enzyme that regulates DNA topology by generation of short-lived DNA double-strand breaks primarily during transcription. TOP2β/180 can be a target for DNA damage-stabilizing anticancer drugs, whose efficacy is often limited by chemoresistance.

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DNA Laboratories Therapies Regulations 100

Agency IQ

JULY 22, 2024

BY LAURA DIANGELO, MPH In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry. Fill out the form to read the full article.

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FDA Laboratories Regulations Drug Development 59

FDA Law Blog: Biosimilars

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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Laboratories FDA Regulations Compliance 59

Agency IQ

MAY 3, 2024

BY LAURA DIANGELO, MPH The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations.

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