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Both labels would provide the framework for the consistent placement and order of the regulated portions of pesticide label information, with the digital label organizing the contents as data. The EPA’s Office of Pesticide Programs (OPP) is in the developmental stage of creating a structured pesticide and digital pesticide label.
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.
EPA releases whitepaper for second part of the risk evaluation for asbestos The Environmental Protection Agency has published a whitepaper on the quantitative human health approach to inform the Risk Evaluation for Asbestos, Part 2. However, the majority of this ban was overturned by Corrosion Proof Fittings v.
EPA issues whitepaper exploring the adoption of structured content and digital pesticide labels FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance The EPA’s Office of Pesticide Programs (OPP) is in the developmental stage of creating a structured pesticide and digital pesticide label.
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. Working with a committed and experienced FSP PV partner is often the best way to achieve success.
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The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Download Mettler Toledo’s Pharmaceutical Waters whitepaper to discover how to:
Monitor water for injection in real-time.
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The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Download Mettler Toledo’s Pharmaceutical Waters whitepaper to discover how to:
Monitor water for injection in real-time.
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. .
In an effort to overcome one of the biggest challenges facing the pharma industry today – how to make products efficiently while still meeting safety and quality requirements – this whitepaper introduces real-time TOC monitoring solutions that successfully reduce the risk of product recalls and shutting down production.
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.
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.
Regulators and payors also demand a higher volume of data collection for these studies. Access the whitepaper The post Patient-Centric Strategies for Successful Oncology Trials appeared first on PPD. There is a lot of competition in this area of drug development, and the regulatory landscape is increasingly dynamic.
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.
BY WALKER LIVINGSTON, ESQ | JUL 3, 2024 4:40 PM CDT Background: FIFRA and antimicrobial pesticides Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA is responsible for the regulation of pesticides in the United States. To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com ).
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.
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
here.
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. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.
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.
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 parallel, FOCR developed a whitepaper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint.
Read This paper explains how synthetic biology is regulated in Europe. Read Asimov, a Boston-based company that uses software and a large library of genetic parts to design living cells, published a whitepaper that explains their technology in more detail. .” Nature Genetics. This review is a good place to start.
Read This paper explains how synthetic biology is regulated in Europe. Read Asimov, a Boston-based company that uses software and a large library of genetic parts to design living cells, published a whitepaper that explains their technology in more detail. .” Nature Genetics. This review is a good place to start.
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.
What we expect the EPA to do in March 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.
Effective monitoring of regulatory intelligence comes with big challenges The challenges inherent to PV RI encompass more than just regulatory complexity — though complexity is a major factor, given regulations are continually created, updated or revised, at all levels (regional, national and global), often all at the same time.
Comprehensive audit trails for enhanced compliance and troubleshooting We’ve made significant improvements to firefly’s audit log system to better support both operational and compliance needs, including compliance with FDA 21 CFR Part 11 regulations. supports compliance with 21 CFR Part 11, check out our whitepaper.
LLMs are a useful tool for extracting dense information contained in whitepapers or info-rich tables, such as a schedule of assessments. With that in mind, there will always be a need for an expert who is up to date on regulations to apply their knowledge to the output and ensure the accuracy of content provided.
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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