Food and Drug Administration Reports

CASE STUDY: When GlaxoSmithKline was challenged with improving efficiency in modeling and simulation, their clinical development research team turned to Univa technology for faster methods of establishing and running models for a drug’s effects on the body.

Posted: 03 Apr 2008 | Published: 01 Apr 2008

WHITE PAPER: There is a more positive scenario - a "win-win" - but it is one that will require new levels of accountability, tough decisions and hard work on the part of all stakeholders.

Posted: 22 Feb 2008 | Published: 01 Jan 2006

CASE STUDY: Learn how Kalypsis, a clinical stage pharmaceutical company, is leveraging Xerox DocuShare Enterprise Content Management to control content for regulatory operations and clinical trials.

Posted: 08 May 2008 | Published: 01 Jan 2007

INFOGRAPHIC: Assembling the right team for a digital transformation project is critical. Transformation is a team sport - it requires experience, knowledge and the ability to influence and work with others. In this infographic, we help you figure out who needs to be on your digital transformation team and what are the key skills for each team member.

Posted: 18 Jan 2022 | Published: 18 Jan 2022

WHITE PAPER: When you understand people and their names in context and in real time, you have an increased capability to preempt threats and fraud. Find out what you can do to help protect your business.

Posted: 13 Mar 2008 | Published: 01 Jan 2007

WHITE PAPER: This paper explores how high performance computing solutions from IBM can enable high-velocity financial analytics and trading.

Posted: 17 Jun 2008 | Published: 01 Sep 2007

CASE STUDY: Researchers found that by creating a dynamic IT environment- standardized, centralized, automated, and mobile-California can achieve a greener, more secure computing complex that improves productivity, delivering greater efficiency at a lower cost to taxpayers and the environment.

Posted: 27 May 2009 | Published: 27 May 2009

WHITE PAPER: Due to the financial meltdown in the mortgage-backed securities industry, new compliance requirements will be implemented. Read this paper to find out how organizations can ensure compliance with stricter regulations and manage risk appropriately so the business does not slip into non-compliance resulting in negative publicity or punitive fines.

Posted: 20 Feb 2009 | Published: 20 Feb 2009

EGUIDE: The FDA has issued a warning to retailers and consumers regarding elevated lead levels in ground cinnamon.

Posted: 07 Aug 2024 | Published: 07 Aug 2024

WHITE PAPER: The FDA's new Section 524B mandates cybersecurity requirements for medical devices. This guide covers navigating the regulations, including monitoring vulnerabilities, secure design, patching, and software bill of materials. Read the full guide to learn how to ensure your medical devices meet the new cybersecurity standards.

Posted: 17 Jun 2024 | Published: 17 Jun 2024

EBOOK: This white paper outlines 10 key security principles for designing secure medical systems, including data encryption, secure boot, hardware partitioning, and input validation. Implementing these principles can help protect against cyberattacks and safeguard patient health. Read the full white paper to learn more.

Posted: 17 Jun 2024 | Published: 17 Jun 2024

EBOOK: As healthcare systems become more connected, cybersecurity for medical devices is critical to mitigate risks. This white paper examines the key considerations for implementing an effective security strategy throughout the device lifecycle. Read the full white paper to learn more.

Posted: 17 Jun 2024 | Published: 17 Jun 2024

PRODUCT OVERVIEW: Open source Linux is cost-effective and customizable for medical device development but presents security and compliance issues. Wind River Linux offers an advanced embedded platform with robust security, compliance support, and lifecycle management, aiding innovation and risk reduction in medical devices. Learn more in the full overview.

Posted: 17 Jun 2024 | Published: 17 Jun 2024

WHITE PAPER: Designing secure, reliable software update capabilities is crucial for medical devices to meet evolving regulatory requirements and improve patient safety. Learn how Wind River's virtualization, real-time OS, and cloud-native solutions can help you build in these critical update capabilities. Read the white paper.

Posted: 17 Jun 2024 | Published: 17 Jun 2024

EGUIDE: Artificial womb technology may present an opportunity for better outcomes among preterm infants; however, it also comes with many challenges.

Posted: 09 Jul 2024 | Published: 09 Jul 2024

EGUIDE: In the healthcare industry artificial intelligence is now a game-change supporting medical research, patient care and overall system operations. Predictive tools for spine surgery outcomes were surpassed by a machine learning approach that combined ecological momentary assessment data, wearable data and electronic health records.

Posted: 28 Jul 2024 | Published: 29 Jul 2024

WHITE PAPER: The changes happening to today’s retail pharmacy landscape are undeniable, and while dispensing medication safely and efficiently may still be at the core of what these pharmacies do, this line of business alone won’t keep them profitable in the long run. Take the first step towards creating a future-ready retail pharmacy by opening this eBook.

Posted: 31 May 2024 | Published: 31 May 2024

ANALYST BRIEF: Publishing Test

Posted: 08 Nov 2018 | Published: 08 Nov 2018

EGUIDE: In this e-guide, read about the promises of healthcare data analytics, the challenges faced by healthcare providers in digital transformation and what some cloud providers are doing to assuage the security concerns of cloud among healthcare service providers.

Posted: 08 Feb 2021 | Published: 25 Feb 2020

EZINE: With countries the world over reeling from the Covid-19 coronavirus outbreak, which has meant sweeping changes both economically and socially, Computer Weekly looks at how firms in the Asia-Pacific region have adapted to what has so quickly become the new normal.

Posted: 08 Feb 2021 | Published: 14 May 2020

EBOOK: By enabling real-time data processing on devices without the need for extensive connectivity or system integration, edge AI facilitates a more streamlined and agile approach to data management. Explore the key benefits of the integration between edge computing and government AI in this eBook.

Posted: 28 Feb 2024 | Published: 28 Feb 2024

EBOOK: Download this e-book to find out what to do when your organization is at the AI and sustainability tipping point.

Posted: 06 Jun 2024 | Published: 06 Jun 2024

EDITORIAL RESOURCE GUIDE: Pharmacy benefit managers negotiate prescription drug prices with drug manufacturers and pharmacies on behalf of payers.

Posted: 12 Apr 2024 | Published: 12 Apr 2024

EGUIDE: While GenAI is not expected to supersede other IT priorities such as cloud, application development and cyber security, it will augment those areas by making it easier to build software and improve cyber resilience. In this round-up, we review some of the key IT trends that are likely to shape the industry across the region in 2024.

Posted: 07 Jan 2024 | Published: 08 Jan 2024

EBOOK: From creating a cloud-based digital production platform to combining disparate multimodal data sets, organizations everywhere continue to double-down on cloud investments to streamline infrastructure management and drive business innovation. Browse this e-book to examine cloud innovation tactics for your company.

Posted: 19 Dec 2023 | Published: 19 Dec 2023

EBOOK: From creating a cloud-based digital production platform to combining disparate multimodal data sets, organizations everywhere continue to double-down on cloud investments to streamline infrastructure management and drive business innovation. Browse this e-book to examine cloud innovation tactics for your company.

Posted: 17 May 2024 | Published: 19 Dec 2023

EGUIDE: A wearable, deep learning-driven camera could help healthcare providers proactively identify potential errors prior to medication delivery with 99% accuracy.

Posted: 04 Nov 2024 | Published: 04 Nov 2024

WHITE PAPER: As healthcare shifts to address equity, payers must collect data, engage members, and collaborate with providers to meet new CMS Health Equity Index requirements by 2027. Learn strategies to prepare and drive better outcomes in this white paper.

Posted: 05 Sep 2024 | Published: 05 Sep 2024

EGUIDE: Drugs used to treat ADHD have been lacking for months now, leading to problems with access to prescription amphetamines and creating questions about the cause of the massive shortage. Download the article to know more.

Posted: 19 Jul 2023 | Published: 19 Jul 2023

EGUIDE: HHS finalized a rule that will increase Medicare inpatient payments by 2.9% in FY 2025, among other new payment policies.

Posted: 05 Sep 2024 | Published: 05 Sep 2024

EGUIDE: Delivering physical products to a customer base that today, for many businesses, spans the globe is a huge industry in itself. In this e-guide we look at the technologies that the businesses that operate in the logistics sector are investing in. As the headline suggests, Blockchain and the Internet of Things technologies are amongst them.

Posted: 08 Feb 2021 | Published: 21 Nov 2019

WHITE PAPER: You’ve heard about the massive potential of GenAI. But GenAI also poses many critical challenges and risks for your organization, including a skills gap as well as extreme demands on your computing infrastructure. Download this white paper now to discover key considerations in creating a responsible GenAI strategy.

Posted: 12 Mar 2024 | Published: 12 Mar 2024

EGUIDE: Medicare includes four different segments that each insure a wide variety of services and supplies for enrollees.

Posted: 30 Sep 2024 | Published: 01 Oct 2024