FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.”

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FDA Regulations Production Drugs 105

SCIENMAG: Medicine & Health

JUNE 9, 2023

Accounting researchers at the University of Arkansas are deepening their understanding of the effect of shrinking newsrooms on the financial information of public companies. A new study, […]

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Research Science 72

thought leadership

AUGUST 12, 2024

AI is a highly praised tool to implement across industries and service lines and Medical Information (MI) is no exception. In Medical Information, AI is embedded in a workflow for patients and healthcare providers to access the services more swiftly, and for the MI team to deliver timely and accurate information with elevated quality.

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SCIENMAG: Medicine & Health

AUGUST 29, 2023

29, 2023) Personal devices feed our sight and hearing virtually unlimited streams of information while leaving our sense of touch mostly … untouched. 29, 2023) Personal devices feed our sight and hearing virtually unlimited streams of information while leaving our sense of touch […] HOUSTON – (Aug.

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Engineering 76

Perficient: Drug Development

APRIL 29, 2024

In this blog post, we delve into the concept of perceptible information in audio descriptions and captions, exploring how they contribute to universal accessibility and inclusivity. Understanding Audio Descriptions Audio descriptions provide spoken narrations of visual elements, actions, and contextual information within audiovisual content.

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Marketing 59

thought leadership

JULY 3, 2023

The rapid advancement of artificial intelligence (AI) technology has revolutionized various industries, including the medical information sector. One notable AI-driven tool is ChatGPT, developed by OpenAI.

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Production 75

SCIENMAG: Medicine & Health

AUGUST 28, 2023

Transferring optical information in free space with large bandwidth and high transmission capacity has gained significant attention in various applications, such as remote sensing, underwater communication, and medical devices.

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Science 77

Advarra

SEPTEMBER 29, 2022

Informed consent is one of the central protections the regulations provide to research subjects. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs). The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study.

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Regulations FDA Research Treatment 52

SCIENMAG: Medicine & Health

JULY 3, 2023

A cochlear signal, the exact role of which has been unclear since its discovery around 70 years ago, probably gives the brain information on whether the ear is functioning normally or not. This is the conclusion of a study from Linköping University, Sweden. Its findings are an important piece of the puzzle in explaining what […]

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Perficient: Drug Development

JANUARY 28, 2024

In this installment, we turn our attention to the principle of “Perceptible Information,” a guiding principle that emphasizes effective communication for users, regardless of their sensory abilities. Join us as we explore the significance of making information accessible through various modalities, fostering inclusivity in design.

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Production 52

Perficient: Drug Development

APRIL 22, 2024

In the realm of universal design, ensuring that information is perceptible through various modes of communication is paramount to creating inclusive environments. Let’s explore why understanding perceptible information for multi-modal communication is essential in universal design.

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Perficient: Drug Development

APRIL 22, 2024

Let’s explore why understanding perceptible information is crucial for creating accessible pedestrian crossings and how it contributes to universal design principles. Perceptible information, such as clear signage, audible signals, and tactile indicators, helps pedestrians navigate crossings safely and confidently.

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Compliance Regulations 52

Perficient: Drug Development

APRIL 24, 2024

Inclusive graphic design goes beyond aesthetics; it ensures that information is accessible and understandable to everyone, regardless of their background, abilities, or preferences. Interactive Elements : Implementing interactive features, such as hover effects and tooltips, to provide additional context and information on demand.

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Production 52

SCIENMAG: Medicine & Health

JULY 24, 2023

In the face of existential dilemmas that are shared by all of humanity, including the consequences of inequality or climate change, it is crucial to understand the conditions leading to cooperation.

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Science 84

Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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Broad Institute

JULY 29, 2022

Group tour information By Maria Nemchuk July 29, 2022 Breadcrumb Home Group tour information Welcome Exhibits Plan your visit Book a group tour The Broad Discovery Center offers guided tours to visitors Monday - Wednesday at 11:00 AM, unless otherwise posted. Visitors should gather at the S-shaped sofa in the lobby.

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Science Daily: Pharmacology News

JANUARY 2, 2024

How the brain encodes this information has long puzzled neuroscientists. Our memories are rich in detail: we can vividly recall the color of our home, the layout of our kitchen, or the front of our favorite cafe.

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Research 82

Antidote

FEBRUARY 8, 2023

COPD is a chronic, inflammatory lung disease that obstructs the airflow to and from the lungs, and common symptoms include a continual cough, shortness of breath, excess mucus, and chest tightness.For those living with COPD, their loved ones, and their care partners, we’re sharing some helpful resources to gain information and build community.

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Disease 98

Perficient: Drug Development

MARCH 12, 2024

Refer to this link for more information: Item Renderings – Sitecore PowerShell Extensions. Then, using the placeholder key “Footer” and layout “FinalLayout,” it tries to list out access “footer” rendering information for each versioned item.

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Perficient: Drug Development

APRIL 22, 2024

Let’s delve into why understanding perceptible information for clear and consistent feedback is crucial in universal design. Feedback Loop Clear and consistent feedback creates a feedback loop between users and their environment or interaction, enabling individuals to understand the outcome of their actions and make informed decisions.

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Production 52

Agency IQ

NOVEMBER 20, 2023

In 2022, the European Commission, Heads of Medicines Agencies and EMA established a common standard for electronic Product Information, or ePI, an electronic representation of information patients usually receive in paper format along with their medicines.

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Production 52

NIOSH Science Blog: Drugs

JUNE 7, 2023

Contributing quality, plain language health information in multiple languages to Wikipedia increases its accessibility and reach. Lack of safety and health training and language barriers are among the most frequently cited challenges companies face in promoting safety among immigrant workers (Flynn, 2014).

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International 79

Perficient: Drug Development

APRIL 30, 2024

Tactile elements serve as vital components in achieving this goal by providing perceptible information through touch. The Importance of Tactile Elements Tactile elements, such as textured surfaces, raised patterns, and braille signage, offer vital cues and information to individuals with visual impairments or other sensory disabilities.

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Perficient: Drug Development

APRIL 24, 2024

Among these features, tactile paving stands out as a crucial element, providing perceptible information to aid navigation. These patterns are typically made of contrasting materials, such as raised dots or bars, and are strategically placed to convey information about the environment’s layout, hazards, or points of interest.

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Perficient: Drug Development

JUNE 24, 2024

You also need a strong healthcare information architecture (IA) strategy in place. Healthcare information architecture defines the navigational experience Your visual sitemap and URL maps are very important to the IA process. And it’s probably not going to help you with your conversion goals. But they’re internal artifacts.

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Common Sense for Drug Policy Blog

AUGUST 18, 2023

Information Sharing and Performance Enhancing Drugs "Peers and social networks are an important component of the performance and image enhancing drug (PIED) community. However, the Internet has shifted the way those who consume substances seek and share information [ 17 ]. Davey et al. [ Harm Reduct J. 2017 Jul 21;14(1):48.

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Drugs Research 40

PPD

OCTOBER 12, 2023

Parallels between pharmacokinetic (PK) analyses for CGTs and immunotherapies, conducted through PCR-based assays and plate-bound antibody assays, respectively, can inform a successful approach. The post Informed Design of Bioanalytical PCR Assay Testing Parameters appeared first on PPD Inc.

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Agency IQ

AUGUST 18, 2023

FDA’s informed consent guidance gets a 21st century makeover The FDA has issued a new, final guidance on informed consent for clinical investigations – the first update since 1998. The FDA, HHS, and research and informed consent policies In the U.S.,

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FDA Clinical Trials Clinical Research Regulations 52

Perficient: Drug Development

SEPTEMBER 25, 2023

This is where Salesforce Knowledge, a powerful feature of the Salesforce platform, comes into play, revolutionizing how businesses manage and provide information to their customers, partners, and employees. In the subject write – Please provide the features or information of Mobile. The same goes for the description. Click Save.

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Production 59

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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FDA Clinical Trials Trials Government 64

SCIENMAG: Medicine & Health

JUNE 9, 2023

Polygenic risk scores, where genomic information alone is used to assess the risk of developing diseases, have been receiving a lot of attention recently, but research to be presented at […]

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Disease Research 65

Collaborative Drug

NOVEMBER 28, 2023

Vault Snack #21 – Managing Sample Inventory Information in CDD Vault

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Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use.

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. The bill proposes to amend FDC Act § 505(b) and PHS Act § 351(a)(2) with respect to patent information submitted to FDA for Orange Book and Purple Book listing. Koblitz & Kurt R.

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FDA Biosimilars Drugs FDA Approval 105

SCIENMAG: Medicine & Health

FEBRUARY 12, 2024

Ultra-processed foods make up more than half the food average Americans eat. Including frozen and prepared meals, most packaged snacks, desserts and carbonated soft drinks—but also including more innocuous foods—they are often considered the bane of healthy eating, containing little to no nutrition to fuel healthy bodies.

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Packaging 76

SCIENMAG: Medicine & Health

JANUARY 18, 2024

Reston, VA—A novel imaging approach, 68Ga-pentixafor PET/CT, has been shown to accurately identify sub-types of primary aldosteronism (an adrenal gland disorder), outperforming traditional methods for diagnosis.

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Science Daily: Pharmacology News

JUNE 5, 2023

Researchers have demonstrated the principle of using spatial correlations in quantum entangled beams of light to encode information and enable its secure transmission.

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Research 68