Eye on FDA

AUGUST 10, 2023

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. And the increase in profile of Spanish releases would also be higher when there are fewer press releases if the number of bilingual communications remained the same. Overall, there have been shifts in the way the agency is communicating.

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Communication Documentation 80

GMPSOP

OCTOBER 16, 2022

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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Documentation Data Entry Communication Packaging 40

Express Pharma

JULY 9, 2024

The US Food and Drug Administration aims to advance its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. However, not all information found online about medical products is reliable.

Communication 105

Communication Documentation 105

pharmaphorum

JUNE 22, 2021

The UK’s Department of Health and Social Care has published a document setting out its strategy on handling patient data – and defending its plan to transfer millions of GP records into a centralised database. The post UK gov’t defends NHS data sharing plans in strategy document appeared first on.

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Documentation Health and Personal Care Stores Medical Records Communication 52

FDA Law Blog: Biosimilars

JUNE 10, 2024

Below we highlight FDA’s views about best practices for BIMO inspection communications, handling requests for records, and inspection preparation and follow-up as outlined in the draft guidance. FDA investigators routinely share their names, titles, contact information, and, when appropriate, reasons for conducting the inspection.

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Communication Documentation 109

European Pharmaceutical Review

MAY 18, 2023

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

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Documentation Communication 98

pharmaphorum

JANUARY 26, 2023

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. “With its wide reach and international audience, information on medicines can be seen by audiences it wasn’t intended for.”

Communication 105

Communication Documentation 105

RX Note

JULY 15, 2023

Introduction Medical/case note entries are legal documentation of all contributions made by healthcare providers in a patient's care. It facilitates effective communication among healthcare providers by enabling the sharing of concise, informative and auditable records.

Documentation 52

Documentation Communication 52

PharmaState Academy

MARCH 8, 2024

CASE STUDY Enhancing Interpersonal Skills Effective Communication with Multidisciplinary Healthcare Teams Table of Contents Case Study Context and Background: In the dynamic landscape of pharmaceutical sales, effective communication with multidisciplinary healthcare teams is paramount. Their task?

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Communication Documentation Hospitals 52

Pharmaceutical Technology

MAY 18, 2023

The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. The EMA set up a task force in 2016 in light of issues concerning medicine availability and supply chain.

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Online Pharmacies Communication Documentation 99

Viseven

JULY 25, 2024

Ensuring the accuracy and authenticity of all your content Every pharmaceutical or healthcare organization, company, or even small business that creates and publishes any type of content faces a huge responsibility: providing both healthcare professionals and patients with true information backed by facts, studies, and other evidence.

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Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

Eye on FDA

NOVEMBER 17, 2020

It would appear plausible based on the information gleaned from the data announcements that there could be a filing for an EUA very shortly which could in turn mean that limited vaccinations could start being administered very soon. And also how will those who do not vaccinate because of medical or religious reasons be considered?

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Communication Vaccines HIPAA Documentation 81

GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

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Documentation Customer Service Health and Personal Care Stores Communication 59

Eye on FDA

OCTOBER 19, 2022

The emergence of pharma on TikTok signals another facet in the evolution of healthcare communications and a similar pattern. Communicators and marketers would love black and white answers about concrete platforms. And they believe that the principles laid out to date cover pretty much any communications platform. Does FDA know?

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Communication Documentation 89

FDA Law Blog: Biosimilars

JUNE 27, 2023

FDA now seeks comments on this very program to support its continued collection of information as required under the Paperwork Reduction Act. On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH.

Documentation 57

Documentation Labelling Communication 57

pharmacy mentor

OCTOBER 22, 2024

This technology is reforming the management of prescriptions, enhancing the accuracy of medication dispensing, streamlining communication with healthcare providers, and allowing pharmacists to devote more time to patient care. In traditional settings, communicating such critical information can take hours or even days.

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Communication Prescription Management Medication Dispensing Payment Processing 52

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

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Communication Documentation Labelling Pharmaceutical Companies 64

FDA Law Blog: Biosimilars

MARCH 7, 2023

If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission.

Documentation 57

Documentation Communication 57

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Pulses

SEPTEMBER 26, 2023

This shift highlights the significance of effective communication, teamwork, and adaptability. Despite the challenge of quantifying these skills, their influence on a student’s ability to cultivate professional relationships, effectively communicate, and collaborate in a team cannot be overstated. teacher), entertainment (ex.

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Communication Hospitals Documentation 59

pharmaphorum

MAY 25, 2022

“Where it is impossible to restrict access to HCPs, due to the congress platform or equivalent, there must be a clear statement to the attendee that the materials/communication are designed and intended for HCPs only.”. Here, we take a look at the top five takeaways from the document: 1. The codes still apply. End of the host country.

Documentation 105

Documentation Communication Pharmaceutical Manufacturing Labelling 105

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

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Packaging Documentation Labelling Dosage 52

Putting Patients First Blog

MARCH 18, 2024

While implementing this new program, it will be critical that CMS work with patients, patient advocacy groups, and other stakeholders to support choice and access to clear, understandable, and actionable information. The NHC provides the following technical comments on the MPPP Part Two guidance.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

While implementing this new program, it will be critical that CMS work with patients, patient advocacy groups, and other stakeholders to support choice and access to clear, understandable, and actionable information. The NHC provides the following technical comments on the MPPP Part Two guidance.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. However, in contrast to DMCs, such an entity should remain blinded to efficacy data.

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Documentation Adverse Reactions Communication Drug Development 104

Board Vitals - Pharmacist

DECEMBER 1, 2023

Patient Communication Some call it creating “happy patients,” others want to improve “patient experience,” and yet others mention “patient satisfaction.” Regardless of the term you use, communicating with patients in order to improve their care, compliance, and satisfaction is a worthy goal. It’s much easier said than done.”

Communication 98

Communication Documentation Diabetes 98

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

Pharmaceutical Technology

SEPTEMBER 5, 2022

The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health. Furthermore, digitisation has simplified the process of gaining information on the drugs being prescribed.

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Pharmaceutical Companies Pharmaceutical Companies Communication Documentation 52

GMPSOP

MAY 26, 2023

Imagine your company is going to install new information management software in the laboratory to replace the old one. The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. Additional documents included each month.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Imagine your company is going to install new information management software in the laboratory to replace the old one. The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Additional documents included each month.

Documentation 52

Documentation Packaging Communication Customer Service 52

PharmaState Academy

MARCH 6, 2024

You foster an environment of open communication and collaboration, where every voice is heard and valued. Observations will focus on non-verbal cues, communication styles, and interpersonal dynamics between sales representatives and healthcare professionals.

Communication 52

Communication Documentation 52

Pharmaceutical Technology

SEPTEMBER 14, 2022

The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing or hiring decision. Prospects of clinical dose companies in contract marketing.

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Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Putting Patients First Blog

JANUARY 22, 2024

Director, Patient Advocacy, Pfizer Health literacy is defined according to Healthy People 2030 as the degree to which individuals have the ability to find, understand, and use information and services to inform health-related decisions and actions for themselves and others. and available in English and Spanish. Health.gov.

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Documentation Communication Hospitals 40

pharmaphorum

NOVEMBER 15, 2021

These must be submitted into the Clinical Trials Information System (CTIS), part of the EU Database, portal, no later than 12 months after the protocol-defined end of the study. The lay summary project, then, fulfils a “current and future need” to provide information in a “transparent, reliable, objective way”. Boosting engagement.

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Documentation Communication Hospitals 98

FDA Law Blog: Biosimilars

JULY 7, 2024

However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements. To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category.

Labelling 62

Labelling Communication Documentation 62

Big Molecule Watch

JUNE 4, 2024

Selected participants of the program will have the opportunity to obtain increased communication with FDA officials and receive advice for addressing their program-specific needs, including clinical study design, choice of control group, fine-tuning the choice of patient population, leveraging nonclinical information, and product characterization.

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Documentation Communication Biosimilars 67

FDA Law Blog: Biosimilars

AUGUST 9, 2023

The content and prescription information elements required by 21 C.F.R. Two licensed pharmacists must directly communicate the transfer. The transferring or receiving pharmacist must ensure that the populated information is complete and accurate. (to be codified at 21 C.F.R. cannot be altered during the transmission.

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Controlled Substances Documentation Communication 52