Roots Analysis

MARCH 8, 2023

Traditionally, text and images were printed on pharmaceutical products to convey important information. In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space.

Labelling 52

Labelling Communication Packaging 52

Viseven

JUNE 18, 2025

Scientific communication : Drafting slide decks, scientific responses, medical information letters, and training content using generative models, ensuring scientific accuracy and compliance in messaging and content. Clinical trials One reason clinical trials fail is choosing the wrong patients.

Labelling 52

Labelling Communication Documentation Pharmaceutical Companies 52

pharmaphorum

AUGUST 24, 2020

In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. .

Labelling 128

Labelling Communication FDA 128

PharmExec

JULY 7, 2023

Newly-issued final guidance focuses on language used when communicating quantitative efficacy or risk information.

Labelling 52

Labelling Communication FDA 52

pharmaphorum

OCTOBER 6, 2020

Making real-time data accessible to the consumers of the information when and where it’s needed increases the likelihood of buy-in to the system’s value-add. In this way, manufacturing scheduling can be optimised, and batch release decisions more informed. Label Authoring and Tracking. Label Authoring and Tracking.

Documentation 114

Documentation Communication Labelling Data Entry 114

BuzzRx

JANUARY 27, 2023

The term “on-label use” of a drug may seem unfamiliar to most people. In short, this practice is referred to as “off-label” drug use. Surveys have shown that approximately 1 in 5 prescriptions in the US are for off-label use. In certain populations of patients, off-label drug use is even higher.

Labelling 52

Labelling FDA Dosage Pharmaceutical Companies 52

Pharma Marketing Network

MARCH 31, 2025

As industry leaders adapt to digital-first communication and omnichannel engagement, the need for smart, scalable, and strategic marketing tactics is more urgent than ever. Similarly, patients benefit from communications that resonate with their condition, treatment stage, and lifestyle.

HIPAA 52

HIPAA Communication Labelling 52

Pharma Marketing Network

APRIL 20, 2025

Introduction Is Big Pharma a villainous label or a misunderstood brand? This article explores the nuances of how this label affects pharmaceutical marketing and what brands can do to respond strategically. Be proactive in communication. This means silence or vagueness can be just as damaging as bad publicity.

Labelling 52

Labelling Communication 52

The FDA Law Blog

JUNE 18, 2025

This multidisciplinary team will “pre-review” the submitted information and convene for a “1-day ‘tumor board style’ meeting,” drawing on Commissioner Makary’s experience as a surgical oncologist. Such benefits during the IND phase include “enhanced communication” and “prompt responses.” Addressing unmet public health needs.

FDA 59

FDA Communication Labelling 59

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

Labelling 52

Labelling Packaging Documentation Dosage 52

Hospital Pharmacy Europe

JANUARY 16, 2025

Here, lead author and focus group chair Hala Fadda discusses the reasons for widespread off-label prescribing, the FIP studys rationale and main findings, compounding challenges and considerations for improving clinical practice. Improved data sharing is needed to ensure healthcare facilities worldwide can access this information.

Compounding 119

Compounding Labelling Dosage Hospitals 119

European Pharmaceutical Review

JANUARY 23, 2023

Through EMA’s engagement with its stakeholders, the Medicines Shortages Steering Group has received up-to-date information from community pharmacists on the situation in pharmacies across the EU. Based on current information from companies and stakeholders, it is expected that the situation will improve in the coming months.

Packaging 98

Packaging Compounding Labelling Communication 98

The FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Labelling 59

Labelling Communication FDA 59

Pharma Marketing Network

JUNE 15, 2025

Imagine managing a stadium-sized audience where each person expects personalized, relevant communication—and regulators are watching every move. Missteps in off-label promotion or data security can trigger legal and reputational risks. Seamless data syncing ensures that the most current information drives each message.

HIPAA 52

HIPAA Labelling Communication FDA 52

ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. By Li Jie of ClinsChain

Adverse Reactions 52

Adverse Reactions Packaging Communication Labelling 52

pharmaphorum

OCTOBER 27, 2022

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

IDStewardship

JUNE 6, 2023

Patient Education and Adherence : AI chatbots or virtual assistants can be developed to provide patients with on-demand information about their medications, dosages, potential side effects, and adherence strategies. This empowers patients to make informed decisions and fosters better medication adherence.

Patient Care 130

Patient Care Prescription Filling Hospitals Medication Dispensing 130

Pharmaceutical Technology

JUNE 18, 2025

Subjects who conclude the trial will be qualified for an open-label extension trial. By GlobalData Learn more about Strategic Intelligence The study is assessing the safety and efficacy of 15 mg or 30 mg of the therapy against a placebo, administered once daily for 12 weeks to those with genetically and phenotypically defined MELAS.

FDA 52

FDA Communication Hospitals Packaging 52

Pharmaceutical Technology

JULY 20, 2022

Ganio says that, ideally, once an individual receives a positive Covid-19 result, they should call their pharmacy or communicate through a drive-through facility to minimize the risk of exposure. The updated guidance still mandates a patient to be referred to a physician or other healthcare professionals if this information is not available.

Labelling 111

Labelling Community Pharmacies Medical Records FDA 111

pharmaphorum

OCTOBER 4, 2022

Such non-device CDS are: (1) not intended to acquire, process, or analyse a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system (Criterion 1); (2) intended for the purpose of displaying, analysing, or printing medical information about a patient or other medical information (e.g.

FDA 105

FDA Documentation Labelling Communication 105

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

Packaging 52

Packaging Labelling Communication Pharmaceutical Companies 52

Pharmaceutical Technology

JANUARY 24, 2023

The multi-centre, open-label, single-arm clinical trial has been designed to evaluate the efficacy, tolerability, and safety of a single dose of NGN-401 delivered using a one-time ICV procedure. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

FDA 83

FDA Labelling Communication 83

The FDA Law Blog

AUGUST 11, 2024

on July 17, 2024 for a social media post published by Instagram influencer Brittany Mahomes (who has 2 million Instagram followers) about AUVI-Q (epinephrine injection, USP) that “entirely omit[ed] all risk information” about the drug. The first Untitled Letter was issued to kaleo, Inc. Thank you, Kim, for paving the way here.

FDA 59

FDA Labelling Communication 59

The FDA Law Blog

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

FDA 71

FDA Documentation Labelling Method Validation 71

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.”. Identifying the appropriate code and label. Here, we take a look at the top five takeaways from the document: 1.

Documentation 105

Documentation Communication Labelling 105

pharmaphorum

DECEMBER 7, 2020

Wokingham, United Kingdom — 7 December 2020 — PRISYM ID, a leading provider of regulated content and label management solutions for the life sciences sector, announced today that PRISYM 360 version 1.10 PRISYM 360 and SAP technologies communicate through a web service using standard SAP components with no intermediate stages.

Labelling 52

Labelling Communication 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.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

The FDA Law Blog

NOVEMBER 29, 2023

Considerations include transparency regarding the data used to develop the change, comprehensive testing of the change, characterizing the performance of the device before and after the change, and plans in place for ongoing monitoring of device performance and communication of any unexpected changes in performance.

FDA 115

FDA Labelling Communication 115

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.

Communication 83

Communication Labelling 83

Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

Packaging 40

Packaging Labelling Communication Pharmaceutical Companies 40

The FDA Law Blog

OCTOBER 10, 2022

Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.

FDA 52

FDA Labelling Documentation Communication 52

SingleCare

OCTOBER 7, 2019

Health literacy is the patients ability to obtain, process, and understand basic health information and services needed to make appropriate health decisions, according to the U.S. Meaning, the vast majority of patients may not be able to read and fully understand their prescription labels or follow-up instructions. Use Ask Me 3.

Labelling 52

Labelling Medication Labelling Dosage Communication 52

The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

FDA 75

FDA Documentation Packaging Communication 75

The FDA Law Blog

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.

FDA 59

FDA Documentation Labelling Communication 59

Pharmaceutical Technology

DECEMBER 16, 2022

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Labelling 59

Labelling Communication FDA 59

The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. The questions are generally targeted on determining what information needs to be included in the 510(k).

Documentation 52

Documentation Labelling Communication FDA 52

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

Labelling 105

Labelling Insurance Communication FDA 105