pharmaphorum

SEPTEMBER 29, 2022

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device. not a medical device, ii.

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Pharmaceutical Technology

JULY 19, 2022

However, as more firms are called upon to confront social inequity, corruption, tax avoidance, and a lack of security, healthcare providers and pharma and medical device businesses will need to improve their governance. As a result, medicine and medical supply shortages were a frequent occurrence.

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FDA Law Blog

APRIL 12, 2023

will present a webinar entitled “ Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C.

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Cloudbyz

NOVEMBER 14, 2023

Clinical trials play a pivotal role in bringing new medical devices to market, ensuring their safety, efficacy, and compliance with regulatory standards. This inefficiency can result in increased trial timelines and costs, potentially impacting the device’s time-to-market.

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pharmaphorum

SEPTEMBER 27, 2022

Five wearable devices that monitor patients with Parkinson’s disease as they go about their lives have been given a provisional recommendation from NICE, making them available via the NHS while additional data is collected.

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XTalks

DECEMBER 11, 2023

Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. Let’s examine the list of the top ten fastest growing medical device companies in 2023, ranked by their compound annual growth rate (CAGR). million, marking a substantial 43.8

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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World of DTC Marketing

MARCH 3, 2022

INSIGHT: Yes, for information on medications, but not for general health information or questions. While social media is a resource for new treatments, it’s hard to determine just what is OBJECTIVE and what’s not. It’s a huge mistake to think that Boomers aren’t using digital resources, including telehealth.

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Roots Analysis

FEBRUARY 7, 2023

Over the past decade, numerous scientific and technological breakthroughs in the medical device CROs industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for advanced and minimally invasive medical devices has been augmented due to the increase in expenditure on healthcare.

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FDA Law Blog

MARCH 19, 2024

is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers.

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Pharmaceutical Technology

AUGUST 4, 2022

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Secondary prevention and certain chronic diseases present a particular opportunity to add new value beyond the lab.

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Pharmaceutical Technology

NOVEMBER 7, 2022

SHL Medical is a world-leading solutions provider for advanced drug delivery systems with a unified purpose to further enable patient independence. Currently, SHL Medical has four locations, in Switzerland, Taiwan, Sweden, and the US, with Taiwan being the main manufacturing location. Choosing Charleston. It just felt right.

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XTalks

FEBRUARY 14, 2024

International Childhood Cancer Day focuses on uniting individuals, healthcare professionals and organizations at a global level to raise awareness, improve understanding and encourage advocacy for access to resources that help combat pediatric cancer.

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Pharma in Brief

MARCH 21, 2022

The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. Interim Order No. 1 and IO No. 1 and IO No. 2 was set to expire on March 1, 2022.

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WCG Clinical

APRIL 3, 2023

Princeton, NJ, April 3, 2023 : WCG Clinical announces the relaunch of its publication FDAnews, a trusted resource for pharmaceutical and medical device insights for more than 50 years. The post WCG Clinical Announces Relaunch of FDAnews as the Premier Source for Drug and Device Insights appeared first on WCG Clinical.

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XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. The number of registered studies from 2000 to 2022 on the ClinicalTrials.gov website. Source: [link]. Why Work for Medpace?

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Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S. The regulation has been in flux since 2015.

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The Pharma Data

SEPTEMBER 10, 2020

Johnson & Johnson Medical Devices Companies Launches ‘My Health Can’t Wait’ To Encourage Patients to Prioritize Their Health and Give Them the Information They Need to Pursue Care with Confidence. SOMERVILLE, N.J. 1, [1] My Health Can’t Wait is a U.S. 1, [1] My Health Can’t Wait is a U.S.

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WCG Clinical

NOVEMBER 20, 2023

Insufficient Regulatory Status Information The first category includes missing or insufficient regulatory status information about the test article utilized such as: drugs, vaccines, biologics, medical devices, combination products, dietary supplements, or human cells, tissue, and cellular and tissue-based products (HCT/Ps).

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Advarra

AUGUST 31, 2022

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and emerging biotech companies are facing increasingly complex pathways to successfully bring their innovative ideas to the market. Device description. Intended use.

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Pharma Marketing Network

JULY 27, 2023

Developing strong and meaningful relationships with Healthcare Professionals (HCPs) is vital for healthcare organizations, pharmaceutical companies, and medical device manufacturers alike. Consider organizing workshops, webinars, or conferences to share valuable medical insights, research, and developments.

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XTalks

NOVEMBER 7, 2023

Medical science liaison jobs are crucial since they serve as conduits between healthcare enterprises and medical professionals. Delving into the details of the medical science liaison profession can aid you in assessing whether it aligns with your career goals. What Is a Medical Science Liaison and What Do They Do?

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR.

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pharmaphorum

SEPTEMBER 8, 2022

The Digital Medicine Society (DiME) is today releasing a new set of open-access resources to advance the use of nocturnal scratch in the treatment of atopic dermatitis (AD). . As yet, no new medical product has been approved on the basis of a digital endpoint.

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WCG Clinical

MARCH 4, 2024

Developed to combat some of the pervasive challenges involving resource constraints throughout the clinical research industry, this innovative offering aims to revolutionize how organizations approach statistical analysis and decision-making. ” For more information about WCG’s Statistical Consulting Solutions, please visit [link].

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FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

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Cloudbyz

JUNE 19, 2023

In recent years, the field of pharmacovigilance and drug/device safety has witnessed remarkable advancements in the use of artificial intelligence (AI). Accelerating Signal Detection: Signal detection involves identifying potential safety concerns and associations between drugs/devices and adverse events.

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pharmaphorum

OCTOBER 5, 2020

In his new role, Amresh will be responsible for overseeing and coordinating the people, resources and processes required to deliver new solutions and upgrade existing products, primarily around the PRISYM 360 regulated labeling platform for clinical trials supplies and medical device manufacturers.

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ACRP blog

APRIL 24, 2024

Nor, perhaps, are forays into such arenas as site process improvements, quality assurance, safety management, or medical procedure assistance, all of which another CCRC holder told ACRP she has unexpectedly experienced in her work for a trial site.

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XTalks

MAY 9, 2023

Their primary role is to ensure that clinical trials are conducted safely, ethically and effectively, with the goal of producing high-quality data that can be used to support regulatory approval of new drugs or medical devices. Recruiting and managing trial staff, including investigators, coordinators and other support personnel.

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Roots Analysis

OCTOBER 5, 2023

Driven by the increasing need for safe and efficient medical devices and drug delivery systems, the pharmaceutical polymers / medical grade polymers domain is advancing significantly. There has been a rise in the development of polymers for biopharma with improved biocompatibility, biodegradability and functionality.

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pharmaphorum

JUNE 25, 2021

The role of DTx remains in flux however, particularly in light of regulatory changes in the US that allowed for emergency use authorisations of medical devices during the pandemic, doing away with the need for premarket approvals via the 510(k) process.

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Rethinking Clinical Trials

AUGUST 3, 2023

As researchers, we are producers and consumers of the medical literature. If you’re not prepared to see your manuscript appear in a leading medical journal, you should think carefully before posting it as a preprint. More broadly, citations in medical journals often do not reflect the material cited.

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Cloudbyz

OCTOBER 19, 2023

Data Integration: It allows for seamless integration of data from various sources, including electronic health records and wearable devices, ensuring data accuracy and consistency. Site Selection: Data-driven site selection improves trial success rates and reduces resource wastage.

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FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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pharmaphorum

MARCH 15, 2022

Life science companies invest a significant number of resources to engage physicians and patient advocates. Having a strategy that acknowledges and addresses barriers to engagement will help clinical, medical affairs, and commercial teams create meaningful opportunities for patients that yield deeper, more actionable insights.

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