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. .

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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.

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The Checkup by Singlecare

JANUARY 26, 2023

If you’ve worked in a community pharmacy, you’ve likely had the same frustrating conversations about prescription labels over and over. Due to variability in health literacy, studies show that Americans’ level of understanding of prescription label instructions ranges from 53% to 89%.

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PharmExec

JULY 7, 2023

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

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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.

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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.

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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This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and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.

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Labelling Communication FDA 59

European Pharmaceutical Review

NOVEMBER 24, 2022

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

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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.

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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.

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The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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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

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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.

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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.

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pharmaphorum

FEBRUARY 5, 2021

After the ORAL Surveillance data emerged, analysts debated whether the FDA might take action either to remove Xeljanz from the market or – perhaps more likely – update its labelling to reflect the new data and leave prescribing decisions to doctor discretion.

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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.

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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.

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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.

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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.

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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.

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The FDA Law Blog

JULY 7, 2024

However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements. 10] Performance specifications “include all claims made in the labeling for the device,” and “the intended performance of a device refers to the intended use for which the device is labeled or marketed.” [11]

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Labelling FDA Communication Documentation 64

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.

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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.

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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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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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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.

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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.

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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.

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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.

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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.

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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.

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pharmaphorum

NOVEMBER 29, 2022

Both patients were in an open-label extension of the trial, so it is known that they were on the drug at the time of death, though they may have been in the placebo group previously. All the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall.”

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Digital Pharmacist

MAY 25, 2023

Properly organizing medication bottles in a systematic manner where the label is visible may be a good idea. Consider Allergies Communicate with patients to record any known drug allergies in the system. It’s important to ensure that they are either stored away from each other or that there is a distinct way to differentiate them.

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The Checkup by Singlecare

MARCH 8, 2024

It is also used off-label for other forms of anxiety, like agoraphobia, panic disorders, and acute vertigo episodes. An FDA drug safety communication described that combining opioids with benzodiazepines like alprazolam has resulted in serious adverse events related to the additive CNS depression contributed by both types of medication.

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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.

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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).

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Hospital Pharmacy Europe

FEBRUARY 20, 2025

They suggested that pharmacy-specific interventions should include targeted messaging and informative displays at the point of care, clearer labelling on medications to highlight their environmental impact and better access to pharmacy return schemes for unwanted medicines.

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