pharmaphorum

SEPTEMBER 28, 2020

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. The post FDA launches Digital Health Center of Excellence appeared first on.

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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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Documentation 104

European Pharmaceutical Review

MARCH 5, 2024

Artificial intelligence (AI) plays an increasingly important role in the laboratory world, especially in medical diagnostics. Reliable analytical devices and results are indispensable for both product quality and purity and authenticity testing. AI is also discussed in imaging and spectroscopy.

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Labelling 94

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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Definitive Healthcare

JULY 7, 2023

Artificial intelligence and machine learning for medical device companies mgathers Fri, 07/07/2023 - 09:23 Teaser Image Artificial-intelligence-and-machine-learning-for-medical-device-companies.png Teaser Content Uncover the operational implications of AI and ML for medtech and medical device teams’ strategic decision-making.

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FDA Law Blog: Biosimilars

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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Pharmacy Joe

APRIL 9, 2023

In this episode, I’ll discuss whether a pacemaker or implanted cardiac defibrillator (ICD) protects from medication-induced torsades. Episode 807: Does a pacemaker or implanted cardiac defibrillator protect from medication-induced torsades? However, the rate of most pacemakers is not likely to provide protection from torsades.

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Inpatient 59

FDA Law Blog: Biosimilars

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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Documentation 64

FDA Law Blog: Biosimilars

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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Definitive Healthcare

AUGUST 8, 2022

Resource Type Whitepapers & Research Marketo form number 1747 Case Study Buyer's Guide Whitepaper Transforming a sales team with data-driven market intelligence from Definitive … Healthcare data & analytics buying guide for medical device firms Shifting point of care to ambulatory surgery centers Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pa

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Express Pharma

JUNE 30, 2023

The app grants young & upcoming post-graduate doctors access to a wealth of medical and non-medical information, equipping them to stay ahead in the rapidly evolving medical landscape This Doctor’s Day, JB Pharma introduced JB NEXT, app exclusively designed for resident doctors & post-graduate medical students.

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Communication 80

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.

Labelling 52

Labelling 52

Definitive Healthcare

APRIL 21, 2022

Resource Type E-Books Marketo form number 1760 Buyer's Guide Case study Case study Healthcare data and analytics buying guide for medical device firms EndoGastric Solutions, Inc. Medical affairs Uncover key considerations for the evolving role of med affairs in the pre-launch phase.

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Communication 52

Definitive Healthcare

NOVEMBER 2, 2022

Resource Type E-Books Marketo form number 1758 Whitepaper Buyer's Guide eBook Shifting point of care to ambulatory surgery centers Healthcare data & analytics buying guide for medical device firms Launching your medical device: A strategy and execution cross-functional guide Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHov

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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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FDA Law Blog: Biosimilars

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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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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Pharmaceutical Companies Pharmaceutical Companies Labelling Drug Development 97

Express Pharma

JULY 14, 2023

The platform imparted informative sessions on wide range of topics, including investigational skills for counterfeit drugs, legal drafting, blood center inspections, medical devices rules, good regulatory practices. The interactive sessions provided valuable insights and opportunities for skill development.

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FDA Law Blog: Biosimilars

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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Documentation 40

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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Hospitals Vaccines 64

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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Pharmaceutical Companies Pharmaceutical Companies 52

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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Labelling 52

RX Note

JUNE 8, 2023

Introduction Apart from drug safety in pregnancy , ensuring the safety of medications during breastfeeding is another important consideration. In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. If it does, is there any concern on adverse effects?

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Labelling Packaging 52

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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Diabetes Communication 40

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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Diabetes Communication 40

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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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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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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Medical Schools HIPAA Communication 52

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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FDA Law Blog: Biosimilars

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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Documentation Labelling Communication 45

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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Drug Development Diabetes 100

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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Communication 80

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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Diabetes Communication 64

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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Communication Hospitals 98

Pharmacy Joe

MAY 27, 2020

In this episode, I’ll discuss whether a pacemaker or implanted cardiac defibrillator (ICD) protects from medication-induced torsades. Episode 508: Does a pacemaker or implanted cardiac defibrillator protect from medication-induced torsades? However, the rate of most pacemakers is not likely to provide protection from torsades.

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Inpatient 40

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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Communication Hospitals 98

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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Hospitals Pharmaceutical Companies Pharmaceutical Companies 98