FDA cracks down on off-label drug use messaging
Pharmaceutical Technology
OCTOBER 24, 2023
The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.
RFID: The future of smart labelling?
Pharmaceutical Technology
MARCH 22, 2023
What lies ahead for RFID and smart labelling Volpe says “the future is bright” for smart technologies that identify, monitor, and track medications through the supply chain. RFID is an important facet of smart labelling and its evolution, but not the only one.
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Skinny Label and Induced Infringement: The Saga Continues
The FDA Law Blog
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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Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin
Roots Analysis
MARCH 8, 2023
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. Further, smart labels play a critical role in the manufacturing of pharmaceuticals.
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STAT+: Q&A: How the FDA could use AI for drug and device safety surveillance
STAT
AUGUST 20, 2024
Sentinel draws upon clinical records and insurance claims, and the agency uses its analyses to adjust drug labels, convene advisory committees and disseminate drug safety communication, the authors noted.
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12 Medications With Off-Label Uses
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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How to decode prescription labels for your patients
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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Opinion: Current large language models will not fix health care. Here’s what could
STAT
AUGUST 25, 2023
Many see these models as assistants or even potential replacements for time-intensive tasks, like patient-physician communication through the electronic health record. As a result, they have been labeled “foundation models.
From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information
The FDA Law Blog
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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COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again
The FDA Law Blog
AUGUST 23, 2022
Ironically, a recent FDA safety communication points to a potential way out of this dilemma. In this safety communication, FDA advises the public as follows: If you test negative and have COVID-19 symptoms , you test again 48 hours later for a total of two tests.
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FDA Stresses Consumer-Friendly Promotional Labeling, Ads
PharmExec
JULY 7, 2023
Newly-issued final guidance focuses on language used when communicating quantitative efficacy or risk information.
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9 Ways Pharmacies Can Participate in Health Literacy Month
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.
FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications
The FDA Law Blog
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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How Has Social Media Advertising Changed in Pharma
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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Pharmaceutical Marketing in 2025: Trends, Tech, and Targeting That Matter Most
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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FDA-Approved Labeling: Is Enough Enough?
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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Can holograms help in the frontline fight against pharmaceutical counterfeiting?
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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Sharing oncology trial PROs to build the treatment of the future
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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Why intelligent automation is the future for regulation
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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Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor
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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FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD
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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New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry
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.
Prescribing shift for Pfizer’s Paxlovid expands access but draws questions
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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EU antibiotic shortages being monitored by MSSG
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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Paediatric oral compounding: expert insights from a global study
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.
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Can a nasal spray tackle agitation in autism?
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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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma
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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Transformational therapies demand a new mindset
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.
PRISYM 360 Achieves SAP® Certification as Integrated with Cloud Solutions from SAP
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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FDA holds back from action over Xeljanz safety study
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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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
The FDA Law Blog
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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Valuable virtual tools to keep HCPs informed
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.
Navigating Regulatory Challenges in Pharma Marketing: Best Practices
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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The Checkup by Singlecare - Untitled Article
The Checkup by Singlecare
MARCH 31, 2024
Patients should carefully review medication labels and consult healthcare professionals to understand potential side effects before driving. In addition, you should read labels carefully, understand medication interactions, and plan for safe transportation. Openly share your concerns and experiences to receive personalized guidance.
Is it safe to mix Wellbutrin and caffeine?
The Checkup by Singlecare
MAY 23, 2023
Though most commonly prescribed to treat depression, it is sometimes prescribed off-label for attention-deficit/hyperactivity disorder (ADHD) or (the 12-hour extended-release form) smoking cessation. It is also sometimes prescribed off-label for ADHD or smoking cessation. Not all antidepressants work the same way.
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Johnson & Johnson’s Janssen-Cilag unit gets disappointing ‘restricted’ label for PARP drug in EU
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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Digital therapeutics and healthcare innovation
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.
Are Predetermined Change Control Plans on the road to Global Harmonization?
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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It’s a Cruel Summer – Two New OPDP Untitled Letters
The FDA Law Blog
AUGUST 11, 2024
The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The Mirati letter deals with much more nuanced issues than the letter to kaleo.
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8 Ways to Reduce Medication Errors at Your Pharmacy
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.
Words, inclusivity, and the struggle for health equality
pharmaphorum
SEPTEMBER 29, 2022
Effective communication is vital for addressing […] barriers, and language is one of the key tools we use to communicate. Despite this, non-inclusive words, phrases, and labels are often used in scientific publications and clinical trial protocols. Barriers to health. Equitable health.
10 Ways to Reduce Medication Errors at Your Pharmacy
Digital Pharmacist
DECEMBER 6, 2022
Properly organizing medication bottles in a systematic manner where the label is visible may be a good idea. 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. Verify Orders.
4 ways pharmacists can improve health literacy
SingleCare
OCTOBER 7, 2019
Meaning, the vast majority of patients may not be able to read and fully understand their prescription labels or follow-up instructions. The AHRQ also offers Health Literacy Tools for Use in Pharmacies , which includes info to increase pharmacy staffs understanding of health literacy and how to communicate more effectively with patients.
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Bayer sets out a proposed basis for science-based self-care products
pharmaphorum
SEPTEMBER 6, 2022
The first principle, labelled the “Science of the Human”, asserts that self-care products should be rooted in a thorough understanding of human biology and medical insights, while the second, the “Science of Regulation”, calls for independent regulation.
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