Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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ASPET

NOVEMBER 30, 2023

To overcome the limitations in conducting direct research on Lewisite-induced ALI in a laboratory setting, an animal model was developed using phenylarsine oxide (PAO) as a surrogate for lewisite. Cutaneous exposure to Lewisite, a warfare and chemical burn agent, also causes ALI. Further, VEGFA levels were reduced in the lung.

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PPD

JUNE 24, 2024

Patient-centric trials: Trial designs that prioritize patient convenience will be better positioned to gain efficiencies through improved participant recruitment, retention and compliance rates. Regulatory compliance: Navigating and complying with a variety of regulatory requirements, which may vary across different countries, can be complex.

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Alta Sciences

NOVEMBER 4, 2024

With airlocks around the manufacturing and laboratory areas, staff could safely gown and de-gown. Proper documentation and disposal protocols ensured compliance with environmental and safety standards. Furthermore, laminar flow systems were utilized to filter the air, reducing the risk of disrupting airborne particles.

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Drug Patent Watch

JANUARY 9, 2025

Managing Quality and Compliance Quality and regulatory compliance are non-negotiable in pharmaceutical manufacturing. Navigating Regulatory Challenges Regulatory compliance is a complex area, especially for startups. A CDMO should have a mature data integrity program in place, especially in the laboratory.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

FDA noted that because the scope of ISO 13485’s complaint handling requirements are “substantially similar to the QS Regulation for complaints”, FDA believes that laboratories that satisfy the current QSR complaint requirements “will meet the amended QS Regulation requirements” for complaints.

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FDA Law Blog: Biosimilars

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 ). Gaulkin & Jeffrey N.

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Laboratories FDA Regulations Licensing 81

Fierce BioTech

JULY 15, 2024

This webinar explores the regulatory landscape, emphasizing compliance strategies for industries producing pharmaceuticals, medical devices, and related products. Click here to login. Listing Image Alcami_ListingLogo_250x190.png On Demand Start Date Thu, 09/12/2024 - 11:00

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DS in Pharmatics

JANUARY 6, 2025

In the pharmaceutical industry, the successful transition of a drug substance from the controlled environment of the laboratory to large-scale production at a manufacturing plant is critical.

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PPD

OCTOBER 31, 2024

Patient recruitment and clinical laboratory and diagnostic services are the top drug development activities likely to be outsourced, similar to previous reports. Key factors contributing to this trend include the enrollment of hard-to-find patient populations and compliance with complex regulatory requirements.

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Advarra

SEPTEMBER 14, 2023

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. GDP is Key to Maintaining Compliance Want to instill confidence in your GxP?

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Drug Target Review

DECEMBER 11, 2024

Our approach, grounded in Good Laboratory Practice (GLP) and honed through thousands of studies, ensures that even the most subtle toxicological indicators are reliably detected. Sompura, Method Development Team Lead at Sannova Analytical, brings over 18 years of experience in the Bioanalytical Laboratory Department.

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PPD

JULY 20, 2023

For companies that do not have a dedicated, experienced laboratory partner, retesting packaging is a heavy lift with downstream impacts on patient safety. pharmaceutical company enlisted PPD Laboratory services to establish USP-NF <661.2> Recently, a major U.S.

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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

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

Advarra

OCTOBER 1, 2024

Other costs: Other costs commonly overlooked when budgeting for clinical trials are those of laboratory work, medical monitors, staff training, meeting, travel, translators, advertising, and shipping and storing investigational products. This often requires using specific electronic data capture systems and adhering to strict protocols.

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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

Advarra

JUNE 26, 2023

This blog provides key insights and guidance for sponsors and sites as they work to mitigate risks and ensure compliance for a successful FDA inspection. The inspections are usually done prior to a first market application for new drug applications or routine inspections for ongoing compliance.

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The Connected Lab

MAY 31, 2022

Poor interoperability between traditional software applications has meant laboratories must typically use separate, vendor-specific systems to store, manage and analyze data generated by different instrument fleets. The vast majority of pharmaceutical workflows utilize instruments and digital technologies from multiple vendors.

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Drug Channels

OCTOBER 5, 2020

Strategies for Field Team Compliance and Virtual Monitoring Choose from Two In-Depth Tracks and Interactive Roundtables on: Legal and Compliance Innovation and Operations Critical Insights on Overcoming the Challenges and Complexities Amid a Shifting Industry from: Evan Panich, Assistant United States Attorney , U.S.

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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. As a threshold matter, FDA lacks the power to regulate tests developed and used in a laboratory. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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Laboratories FDA Regulations Compliance 59

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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Vial

MARCH 15, 2024

Each role brings unique expertise and responsibilities, collectively upholding standards of efficiency, compliance, and quality within the sponsor’s operations, thus ensuring the smooth execution of research projects. Do CROs Have to Outsource/Utilize Vendors? However, deviations from established protocols can occur.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). At the core of the new FDA Proposed Rule is the redefinition of IVDs to encompass those manufactured by laboratories, leading to a more uniform regulation in line with other IVDs.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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The Pharma Data

SEPTEMBER 9, 2020

. In order to capture and manage large amounts of data while conforming to regulations, laboratories need to transform and be digitalized by unifying data capture and providing an intuitive way of interacting with it. Transition to advanced analytics platforms to accelerate a product’s time-to-market.

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Production Laboratories Compliance Government 52

PPD

OCTOBER 4, 2023

Preclarus dashboards deliver unprecedented reporting scope that exceeds functional-based study reporting and integrates data collected from three main areas — the laboratory, the operations team and the clinical trial site. Challenges faced by sponsors and sites running clinical trials Clinical trials are a complex, high-stakes game.

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The Connected Lab

SEPTEMBER 7, 2022

With some of the brightest, innovative and resourceful minds from across the world of digital science and chromatography, offering the sharpest insights and sagest advice on how to tackle the biggest challenges you face in the lab, there is no doubt that this year’s International Informatics Symposium will be remarkable.

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The Connected Lab

JULY 29, 2022

For pharma and biotech companies, diagnostic laboratories, and contract research organizations, specimen integrity is critical to ensure robust and reproducible results. Biobanks play a crucial role in effectively managing and storing critical scientific data: biospecimens.

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Vial

MARCH 1, 2024

billion in 2023 attributable to its laboratory products and biopharma services segment (53.8% By type of service, clinical research services accounted for the lion’s share of the North American CRO services market, followed by early-phase development services, laboratory services, and consulting services. of total revenue).

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Vial

MAY 20, 2024

Most notably, preclinical research can be distinguished by their need for a series of extensive laboratory testing performed on non-human models, such as cell cultures and animals. Conclusion In conclusion, the roles of preclinical and clinical CROs are distinct but equally important in the drug development process.

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Drug Target Review

DECEMBER 5, 2024

As a result, there is a need for validated AAV testing solutions to meet quality standards as well as compliance and regulatory requirements. Available from: [link] About the author Dr Chelsea B Pratt, BioPharma Segment Marketing Manager at Bio-Rad Laboratories Inc. Bio-Rad, Bulletin 3725 [cited 2024 Oct 28].

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Agency IQ

AUGUST 18, 2023

EPA labs lack proper inspections, watchdog says The Environmental Protection Agency’s Office of Inspector General has published a new report finding that the agency has consistently failed to verify whether agency laboratories comply with hazardous waste requirements.

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Advarra

APRIL 19, 2023

However, the testing itself often occurs in laboratories or some other healthcare setting away from research participants. IVDs meeting this definition are known as laboratory developed tests (LDTs). IVDs meeting this definition are known as laboratory developed tests (LDTs).

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The Pharma Data

NOVEMBER 5, 2020

Between 1986 and 1991, he supervised the construction of a new $4 million laboratory for Virogenetics in Rensselaer, New York. Before embarking on his professional journey, in 1961, Dr. Van Kampen has frequently spoken at national and international conferences.

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The Strateos Blog: Drug Discovery

OCTOBER 27, 2022

The Lab of the Future Congress examines the role of new and emerging technologies The Lab of the Future Congress examines the role of new and emerging technologies to unlock advancements in the scientific research lab through the digitalization of processes in the modern laboratory to better handle challenges now and in the future.

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FDA Law Blog: Biosimilars

JULY 18, 2023

Sampling While the 2022 Report does not specify what specific circumstances might prompt FDA to take samples for testing, of those that FDA collected, 892 of 1,552 samples—57%–tested at FDA laboratories were out of specification or non-compliant. 2022 marked the fifth straight year that FDA labs found an increasing level of noncompliance.

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