FDA Law Blog: Biosimilars

APRIL 25, 2023

510(k), premarket approval application (PMA), Product Development Protocol (PDP), De Novo, or Humanitarian Device Exemption (HDE)] for a device that meets the definition of a cyber device under this section shall include such information as [FDA] may require to ensure that such cyber device meets the cybersecurity requirements. . . .

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Documentation Labelling Communication 105

pharmaphorum

AUGUST 28, 2020

It also claims that the voice analysis tool can help them “understand how they sound to others, helping improve their communication and relationships.”. The globally recognised definition of health includes mental and social well-being in addition to the physical,” he notes. billion takeover by Google – and will be sold at $99.99

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Communication 93

Digital Pharmacist

NOVEMBER 11, 2022

With all the holiday cheer though, definitely comes stress. What will your holiday hours be and has this been communicated to your customers? The earlier you can prepare your community, the easier it will be for everyone to plan ahead. . Send out mass communication to your customers via text message.

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Communication Pharmacy Management 98

Eye on FDA

SEPTEMBER 28, 2022

OPDP engages in a fair amount of formal study related to various aspects of its mission to protect public health by ensuring that prescription drug promotion is truthful, balanced, and accurately communicated.

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Communication Pharmaceutical Companies Pharmaceutical Companies 69

European Pharmaceutical Review

MARCH 5, 2024

This was communicated in a Letter to Industry (medical devices) published by the agency on 20 February 2024. This means updating the definition of medical devices to ensure consistency across borders.”

Communication 104

Communication 104

pharmaphorum

SEPTEMBER 20, 2021

The paradigm shift from in-office visits to mandatory shutdowns was almost instantaneous and reliance on tele-solutions and digital communications consequently shot up. While many HCPs are open to receive digital communications and sampling programmes, one group that is not ready is older HCPs.

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Communication Drug Development 98

Eye on FDA

JULY 14, 2021

It might also be noted that this year the four letters involved five different communications vehicles, two of which were Banner Ads (the subject matter of the most recent letter). But in 2018 there was some definitive output from Dr. Janet Woodcock, then head of the Center for Drug Evaluation and Research (CDER) which houses OPDP.

Communication 90

Communication 90

pharmaphorum

JUNE 14, 2021

They definitely helped get the human story across. There are plenty of rare disease drugs that aren’t so lucky, though, and Sanders says that in order for other treatments to avoid metreleptin’s early reimbursement difficulties more communication between every stakeholder at every stage is vital.

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Communication Diabetes 105

pharmaphorum

MARCH 30, 2021

Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it. There are a number of drivers behind the need to rethink value evidence and value communication. Changes are afoot – what to look for.

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Communication Labelling 83

Putting Patients First Blog

NOVEMBER 13, 2023

In addition to accessible services, the NHC is also strongly advocates for more inclusive communication. Plain language for patients with cognitive, developmental, intellectual, or neurological disabilities should not only be an optional modification, but a mandatory standard across all communications.

Communication 52

Communication 52

pharmaphorum

DECEMBER 24, 2020

Reviewing 2019’s key digital health stories last year I suggested that, while big strides continued to be made, any definitive ‘coming of age’ moment for the sector was unlikely. So, what were the standout changes for digital health, and digital pharma for that matter, in this most unusual of years?

Drug Pricing 126

Drug Pricing Communication 126

European Pharmaceutical Review

MARCH 9, 2023

Research preferences questionnaire To design respectful messaging that would be sent to patients, the POR team worked with the MUSC Biomedical Informatics Center (BMIC) to develop digital workflows that were efficient for researchers and also with enterprise communications. Epic is MUSC Health’s electronic health record.

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Communication 105

Pulses

MARCH 28, 2024

Many definitions in the literature embody what this entails. Core attributes including empathy, integrity, appropriate communication, accountability, and a commitment to reflective practice 2, 3 , and lifelong learning are essential. Professionalism is a complex and multifaceted construct.

Communication 52

Communication 52

ID Stewardship

DECEMBER 12, 2023

The second quote was “pharmacies have diligently transitioned from apothecaries into problem solvers , educators , and communicators.” ” This resonates with me on the topic, as pharmacy preceptors should consider how they can employ AI to help their learners become better problem solvers, educators, and communicators.

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Communication 122

PharmaShots

JUNE 9, 2023

This article explores the definition and importance of multichannel marketing in pharma, as well as the emerging opportunities it presents. With segmentation and automation, emails can be tailored to specific audience segments, ensuring relevant and timely communication.

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Communication Dosage 56

Viseven

AUGUST 29, 2024

As this trend unfolds, it is vital to understand the benefits 5G brings, how it impacts healthcare communication , and how healthcare businesses can leverage it. 5G represents the 5th generation of cellular technology and is the gold standard in wireless communication today. In this article, we will explore these opportunities.

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Communication Hospitals Pharmaceutical Companies Pharmaceutical Companies 52

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Viseven

MAY 24, 2023

For that matter, the attendees could choose between three stages and a more quiet lunch zone for personal communication. The bottom line: chatGPT is not going to replace HCPs for the time being but its integration is definitely a promising direction of development, for the sake of higher professional efficiency and patient safety.

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Customer Service Communication 52

pharmaphorum

APRIL 21, 2022

For now, the only way to definitively diagnose Parkinson’s is by looking at the brain post-mortem. If PreciseDx digital approach is backed up in further studies it could allow early diagnosis and treatment and help patients stave off symptoms for longer.

Communication 64

Communication 64

Pulses

AUGUST 31, 2023

Despite the increasing popularity, definitive classifications of these terms remain elusive, and too often, are used interchangeably. Definitions: Augmented reality (AR) involves superimposing computer-generated virtual images on the real world allowing learners to view and interact with the virtual content in real-time.

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Medication Dispensing Medication Labelling Packaging Labelling 78

Viseven

SEPTEMBER 22, 2022

They are the primary force among other communication channels in marketing. A little bit of rep-triggered email definition (or approved) and broadcast (automated) emails: Rep-triggered (in such well-known systems as Veeva, ‘Approved’) emails are targeted and personalized (only to one client). part of the Patient Support Program?

Communication 52

Communication Medical Compliance 52

Express Pharma

MARCH 8, 2024

This has definitely changed for the better. While career discussions are crucial before marriage, it’s important to encourage open communication where both partners consider relocation options. This part is particularly close to my heart, as when I began my career, there weren’t as many women visibly present in the field.

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Communication 109

pharmaphorum

JUNE 18, 2021

The countless definitions of empowerment have some common denominators: empowerment equates to enabling, equipping or authorising individuals or groups to think, behave and act autonomously, to make their decision in independent, self-directed ways and to assert control over their future. So what does it take to empower carers?

Communication 76

Communication 76

Safe Biologics

DECEMBER 8, 2022

While the term “interchangeable biosimilar” has a precise legal definition in the U.S., ” on which Professor Schneider appeared as a panelist. View ASBM’s recent webinar “Key Factors for Successful Biosimilar Uptake: Europe and US” here. The Lee bill would remove such data requirements.

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Biosimilars Communication Drug Development 100

PharmaState Academy

DECEMBER 24, 2024

Dr. Vijays expertise in Strategic Thinking, Brand Management, Integrated Marketing Communications, Marketing Strategy, Pharma Marketing & OTC Marketing has been instrumental in shaping modern marketing paradigms. Omnichannel marketing (OCE) is a great example of a term whose definition is becoming lost in the noise.

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Communication Pharmaceutical Companies Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

MAY 10, 2023

802(54)(G) (which references CMS’s statutory definition of “practice of telemedicine”). Second, the prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in CMS requirements for telemedicine services set forth at 42 C.F.R.

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Controlled Substances Communication 52

Pharma Marketing Network

DECEMBER 17, 2021

6 This adds a new dynamic for firms depending on the physical workspace to communicate goals and motivate on-site and virtual employees to participate in sustainability programming. Remote workers polled at 90% when asked if they plan to maintain some remote hours moving forward. What’s Next? Track, measure, and improve.

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Pharmaceutical Companies Pharmaceutical Companies Communication 103

FDA Law Blog: Biosimilars

MARCH 7, 2024

As another example, both documents note the possibility that if FDA has safety information relevant to an ongoing study, it may request that the sponsor confirm that the DMC is aware of that safety data and is taking it into consideration, or “request that the sponsor arrange for FDA to communicate with, or even meet with, the DMC.”

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Documentation Adverse Reactions Communication Drug Development 105

ID Stewardship

DECEMBER 3, 2022

By the way, if you are wondering what pedagogy means (which lets be honest many people probably are), here is the definition: the method and practice of teaching, especially as an academic subject or theoretical concept. What Is The Precept Responsibly Podcast & What Does It Mean To Precept Responsibly?

Communication 90

Communication 90

Pharma Marketing Network

FEBRUARY 16, 2021

Of course, you do not need to invite key speakers to your event, but it definitely makes the event more insightful for your attendees. With most communication being virtual, whether it be meetings, events, or conferences, it’s likely to be more challenging to keep your attendees engaged. Keep your Audience Engaged.

Communication 98

Communication 98

pharmaphorum

JANUARY 13, 2021

There is more that we want to do, and we will work with our sponsors on that, but it’s definitely a learning curve.”. The pandemic-driven shift to digital communications has demonstrated it is possible to maintain contacts while working from home, and people have adapted quickly. Re-creating face-to-face.

Communication 89

Communication 89

Pharmacy Joe

OCTOBER 5, 2022

After this procedure where a paralytic such as succinylcholine or rocuronium has been used along with a short-acting sedative such as propofol, ketamine, or etomidate, a definitive plan for ongoing sedation and analgesia must be made. In this state, the patient is aware of their surroundings but cannot act or communicate their awareness.

Hospitals 52

Hospitals Inpatient Communication 52

Pharmacy Joe

NOVEMBER 5, 2023

After this procedure where a paralytic such as succinylcholine or rocuronium has been used along with a short-acting sedative such as propofol, ketamine, or etomidate, a definitive plan for ongoing sedation and analgesia must be made. In this state, the patient is aware of their surroundings but cannot act or communicate their awareness.

Hospitals 52

Hospitals Inpatient Communication 52

Pharmacy Joe

NOVEMBER 5, 2023

After this procedure where a paralytic such as succinylcholine or rocuronium has been used along with a short-acting sedative such as propofol, ketamine, or etomidate, a definitive plan for ongoing sedation and analgesia must be made. In this state, the patient is aware of their surroundings but cannot act or communicate their awareness.

Hospitals 52

Hospitals Inpatient Communication 52

FDA Law Blog: Biosimilars

MAY 14, 2025

If granted, designated AMT holders should communicate updates or proposed changes that could affect the context of use or AMT eligibility. FDA also intends to provide timely advice and to engage in additional communication (e.g., The statute requires that a determination on the request be made within 180 days of receipt.

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Communication Drug Development 59

pharmaphorum

AUGUST 27, 2021

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. If your employer doesn’t mandate that goal definition at the start of each business year, write down your key deliverables regardless.

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Communication Compounding 52

Proxsys Rx

APRIL 1, 2025

340B legislative updates: States opposing manufacturer restrictions Recent legislative proposals aim to redefine program parameters, such as expanding eligible patient definitions and revisiting covered entity eligibility criteria. Tell them theyre paying for it.

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Specialty Pharmacies Hospitals Documentation Drug Pricing 52