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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The 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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FDA 52

The 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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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The 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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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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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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Find Your Script

MARCH 26, 2022

Ask what devices are allowed to be used during rotations. Having medication resources available to look up drug information questions. Be sure to check out our other videos on Pharmacy Study Resources , how to prepare for NAPLEX exam and how to prepare for Residency Applications. Ask questions.

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Vaccines 130

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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The 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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Hospital Pharmacy Europe

NOVEMBER 9, 2023

A new tool to raise awareness of the risk and harm of substandard and falsified medical products among healthcare providers and facilitate their detection, quarantine and removal from the pharmaceutical supply chain has been published by the International Pharmaceutical Federation (FIP).

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Hospitals Documentation 52

ISPE

OCTOBER 27, 2022

Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for patients with unmet medical needs. Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

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ISPE

OCTOBER 27, 2022

Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for patients with unmet medical needs. What Is Digital Health?

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Health and Personal Care Stores FDA HIPAA Communication 52

The 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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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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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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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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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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PharmaShots

FEBRUARY 14, 2023

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers. A similar framework exists for medical devices. In the U.S.,

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PharmaShots

FEBRUARY 14, 2023

Our partnership is part of DTA’s Resource Partner Program, which the organization launched to accelerate the development and post-marketing success of clinically evaluated DTx by building a network of commercialization and product development service providers. A similar framework exists for medical devices. In the U.S.,

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FDA Insurance Communication 40

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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The Thyroid Pharmacist

JULY 14, 2023

Is it possible to get off thyroid medications or regain thyroid function without taking medications when you have Hashimoto’s? 2] In some cases, the person will become hyperthyroid, and the dosage of their medications will need to be reduced. However, this isn’t always true!

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The Checkup by Singlecare

MAY 11, 2023

Pharmacists can have a significant impact on women’s health by providing education, counseling, and medication management services. Medication management : Through dispensing and clinical monitoring, pharmacists play a vital role in ensuring women receive appropriate medications and dosages. What is women’s health?

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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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Board Vitals - Pharmacist

JANUARY 18, 2023

At many medical schools across and beyond the U.S., Instead, as medical educators blend technology with traditional teaching, digital devices are integral to training our 21 st -century clinicians. Some Examples of Technology Enhanced Medical Education. Types and Benefits of Technology-Based Medical Education Platforms.

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The 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

JULY 8, 2022

Preliminary research suggests that hybrid DCTs can reduce trial timing and resources , improve patient-centricity and patient engagement , and expand access and recruitment and increase diversity , mitigate bias, and reinforce inclusion in clinical trials. Each device type has an important role to play in hybrid and DCT trials.

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pharmaphorum

NOVEMBER 8, 2022

The Tempo system brings together a pre-filled insulin pen, the TempoSmart app and a recently-approved Smart Button device that stores and transfers insulin dose-related data from the pen, and can link with compatible devices. Smart insulin pens are expected to drive the insulin pen market from $13.8

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Hospital Pharmacy Europe

MARCH 28, 2024

He acknowledged the turbulence that the profession has recently been experiencing across Europe, particularly ‘major issues like medication and medical device shortages, workforce instabilities, really wild ideas about outsourcing hospital pharmacy services, or environmental and sustainability questions , just to name a few’.

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pharmaphorum

MARCH 31, 2022

Experts believe time spent practising delivery and messaging will reap dividends providing it is grooved into a sales force or medical science liaison (MSL) team’s schedule. She has worked in variety of medical affairs roles at Amgen Europe for the past 13 years.

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pharmaphorum

AUGUST 20, 2020

Dawson, head of strategy, added: “We’re gaining the benefits of independence, with all the buzz and energy of a start-up, while still being able to call on the resources of a global network of world-leading data and digital experts.”. The post Creative agency woolley pau regains independence after buyout appeared first on.

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Hospital Pharmacy Europe

MAY 25, 2023

A joint venture with Genomics England, the genetic research resource is the first of its kind to be launched by a drug safety regulator. In turn, this will enable doctors to target prescriptions so UK patients will receive the safest medication for them, based on their genetic makeup.

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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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Hospitals 143

pharmaphorum

APRIL 13, 2022

A new whitepaper – The Age of Coaching: How pharma sales teams can face the future with confidence –highlights how empowering a coaching culture and ring-fencing time and resources can generate huge rewards. She has worked in variety of medical affairs roles at Amgen Europe for the past 13 years.

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Omnicell

JANUARY 10, 2023

Our teams of certified experts work alongside our customers, at every turn – from medication management strategy to execution and beyond – to ensure ongoing customer success. As a result, disruptions are minimized, resources are optimized, and value is realized faster.

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ISPE

JUNE 15, 2023

™” applies to all life sciences products including pharmaceuticals, medical devices, and hybrid products, as well as equipment and systems facilitating development and production of activities. The life sciences regulatory and guidance environment is evolving as industry moves into the Pharma 4.0™ ™ paradigm.

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pharmaphorum

MARCH 21, 2022

The International Virtual Reality Healthcare Association (IVRHA) held its 6th annual conference in Nashville, Tennessee, showcasing medical extended reality (XR) experiences and the companies impacting the healthcare ecosystem. Medical XR evolution. If pharma joined the event, it would undoubtedly expand the reach of these solutions.

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The FDA Law Blog

SEPTEMBER 27, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. In addition, the ITAP program provides the manufacturer an entire project team and necessary resources to ensure the analytical testing is completed quickly and meets FDA requirements.

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