Eye on FDA

OCTOBER 11, 2023

FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence to a medication may have on the resulting preference for a medicine. Those in promotional communications may wish to take note now.

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Communication Labelling 98

FDA Law Blog: Biosimilars

MAY 11, 2023

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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Labelling Documentation Communication 72

Eye on FDA

AUGUST 17, 2022

You can see early in the chart, FDA maintained a very low volume of communications, and at mid-year in 2017 had issued only 52 releases, rising to 166 for the year. The current downturn in volume could also be attributable in part to the fact that FDA has once again altered somewhat a past communications practice.

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Communication Labelling 75

Express Pharma

MARCH 20, 2025

Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. 2021;398(10300):583-598. 2022;327(6):534-545. doi:10.1001/jama.2022.0078

Diabetes 101

Diabetes Labelling Communication 101

Big Molecule Watch

MAY 3, 2024

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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Biosimilars Communication Labelling Documentation 49

PharmaState Academy

OCTOBER 25, 2023

Scientific Communication for Pharma Marketing - Quiz Competition Participate in the Quiz & learn more about the “Scientific Communication for Pharma Marketing” which is significant to Pharma Marketing & Sales professionals. Winner Prize: The Quiz winner will be awarded Amazon Gift card worth Rs.

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Communication Pharmaceutical Companies Pharmaceutical Companies Labelling 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Labelling Communication 64

PharmExec

JULY 7, 2023

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

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Labelling Communication 52

FDA Law Blog: Biosimilars

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,

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Biosimilars Labelling Communication 59

Digital Pharmacist

OCTOBER 11, 2023

These events can cover various topics, such as understanding prescription labels, proper medication use, managing chronic conditions, and reading nutritional labels. You can host a workshop or seminar at your pharmacy location or at a restaurant in your community.

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Health and Personal Care Stores Communication Labelling 20

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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HIPAA Communication Labelling 52

FDA Law Blog: Biosimilars

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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Labelling Vaccines Communication 40

Pharma Marketing Network

MARCH 27, 2025

The shift is largely due to changes in user behavior, regulatory clarity, and the demand for more personalized, real-time communication. Social is no longer one-way communication. Brands can host live Q&As, respond to comments, and share patient stories in authentic ways that create community and trust.

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HIPAA Communication Labelling 52

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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Packaging Labelling Documentation Dosage 111

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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Labelling Communication Drug Development 128

RX Note

DECEMBER 25, 2024

Off label use information can be found here too. However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. Summary During university years, we are learning medicines by their active ingredient name.

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Biosimilars Community Pharmacies Labelling Communication 52

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.

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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting. Pharma communicators take note.

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Communication Packaging Labelling 68

pharmaphorum

JULY 20, 2021

The US regulator had extended its review of the drug by three months – setting back its action date from April to 29 July – but now says that deficiencies in the marketing application “preclude discussion” of labelling and post-marketing requirements.

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Labelling Communication 98

pharmaphorum

OCTOBER 6, 2020

Lack of communication on how the workforce will be re-purposed post automation implementation can lead to internal unrest and possible attrition”. Label Authoring and Tracking. Lack of communication on how the workforce will be re-purposed post automation implementation can lead to internal unrest and possible attrition.

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Documentation Communication Labelling Data Entry 114

Pharmaceutical Technology

APRIL 17, 2023

However, the treatment’s label features a black box warning that includes increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. He added that there is also a need for FDA-approved products that communicate efficacy and safety on their labels.

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Medical Schools Labelling Communication 96

Eye on FDA

JUNE 14, 2023

The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). Going back and looking through 2020 at the products involved in letters, there have been a total of 17 letters (involving 19 different communications vehicles).

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Labelling Communication 82

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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Communication Pharmaceutical Manufacturing Packaging Documentation 98

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 US FDA has not announced any updates to Lagevrio’s label. How to get Paxlovid.

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Labelling Community Pharmacies Medical Records Communication 111

European Pharmaceutical Review

JANUARY 23, 2023

MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

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Packaging Labelling Compounding Communication 98

Pharmaceutical Technology

JULY 29, 2022

Dr Jeremy Veenstra-VanderWeele, professor of developmental neuropsychiatry at the Columbia University Irving Medical Center, explains that agitation is seen in the minority of autistic teens, who struggle with communication. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

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Communication Labelling Hospitals 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.

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Labelling Communication 52

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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Documentation Communication Pharmaceutical Manufacturing Labelling 105

Eye on FDA

JANUARY 22, 2024

The communications vehicle that was the subject of the letter was a Direct-to-Consumer (DTC) television advertisement that had been submitted for agency review. There is a larger trend that may be in play – not the communications vehicle, but regarding the type of violation cited by OPDP.

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Communication Labelling 86

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

FDA Law Blog: Biosimilars

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] report certain device malfunctions, and.

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Labelling Communication Documentation 64

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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Communication Labelling 78

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. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

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Labelling Packaging Communication Pharmaceutical Companies 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

pharmaphorum

OCTOBER 7, 2021

Rewind to March of 2020, and pharma companies were facing a communication crisis. Other uses include providing a platform for key opinion leaders (KOLs), as well as internal communications to make sure that messages are unified across an organisation. The crisis that changed everything.

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Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 75

Pharmafile

FEBRUARY 28, 2023

Johnson & Johnson (J&J)’s Janssen-Cilag unit has announced that its fixed-dose combination drug Akeega has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for patients with metastatic castration-resistant prostate cancer (mCRPC), but that it should be limited to patients with BRCA1/2 mutations. (..)

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Labelling Communication 49

pharmaphorum

OCTOBER 12, 2018

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label.

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Labelling Communication 52