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A recent whitepaper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized.
Our recent whitepaper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions.
Dive into Medidata’s whitepaper to find out the best practices and new testing methods clinical trial sponsors are using to immerse patients into clinical trials for a better patient experience and for more enhanced data quality.
Download your copy today to find out how to digitally transform your clinical trials. .
But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.
A recent whitepaper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.
For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants.
EPA publishes interagency framework on antifungal and antibiotic resistance from pesticides The EPA has published a draft framework for an interagency collaboration on better understanding the impact of pesticides on the efficacy of human and animal drugs, with a specific focus on the effectiveness of antibacterial and antifungal drugs.
The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.
However, FDA’s vision for OPQ to serve as a “single, agency-wide quality oversight program that applies a uniform set of standards to all regulated products, and which integrates quality review, evaluation, and inspection activities under one authority” was first publicized more than a decade earlier.
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. For
further information on how we process and monitor your personal data click
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The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.” Also this year, the FDA finalized its new rule on overhauling the medical device quality system regulations.
However, FDA’s vision for OPQ to serve as a “single, agency-wide quality oversight program that applies a uniform set of standards to all regulated products, and which integrates quality review, evaluation, and inspection activities under one authority” was first publicized more than a decade earlier.
BY RACHEL COE, MSC JUL 18, 2023 11:14 PM CDT Oncology endpoints: The growing pains of an evolving field FDA approval of a drug or biologic relies on whether there is “substantial evidence” of safety and effectiveness derived from “adequate and well-controlled clinical investigations” according to the Federal Food, Drug, and Cosmetic (FD&C) Act.
Read This paper explains how synthetic biology is regulated in Europe. Read Remember all the new weight loss drugs, like tirzepatide, that celebrities are going crazy for? Well, more data is out, and people who took the drug for 72 weeks “lost up to 15.7% .” Nature Genetics. Nature Communications.
Read This paper explains how synthetic biology is regulated in Europe. Read Remember all the new weight loss drugs, like tirzepatide, that celebrities are going crazy for? Well, more data is out, and people who took the drug for 72 weeks “lost up to 15.7% .” Nature Genetics. Nature Communications.
Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S. Next, the U.S.
Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.
Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.
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LLMs are a useful tool for extracting dense information contained in whitepapers or info-rich tables, such as a schedule of assessments. LLMs are trained using already established content, but clinical research will always consist of new drugs and therapies with a lack of pre-existing written information.
It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “whitepaper” for the Product Liability Advisory Council on the same subject. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. at 77 (citation omitted).
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