Pharmaceutical Technology

MARCH 22, 2023

As computing has developed in the past decade, so has the potential to store and use information in the cloud. 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.

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Labelling Data Entry Communication FDA 105

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

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Labelling Communication FDA 98

STAT

MAY 2, 2024

Department of Agriculture after the agency again failed to include basic information needed to track how the virus is changing as it spreads. All are simply labeled with “USA” and “2024.

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Labelling 145

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Labelling FDA Communication 64

European Pharmaceutical Review

JANUARY 9, 2025

Three industry bodies have produced a joint position paper highlighting recommendations for adopting a harmonised implementation of electronic Product Information (ePI) leaflets. It will also enable more patient-centric and accessible content by providing the most up-to-date information.

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Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

DECEMBER 6, 2024

Because clonidine works differently than other blood pressure medications, it also has several off-label uses including anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), and alcohol withdrawal. Clonidine is a generic medication that treats hypertension (high blood pressure). Clonidine is a centrally-acting alpha agonist.

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Labelling Documentation FDA 98

Drug Store News

APRIL 13, 2023

The ScripTalk label system allows blind or low-vision patients to hear important prescription label information audibly.

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Labelling 98

The Checkup by Singlecare

NOVEMBER 11, 2024

Although trazodone is FDA -approved for depression, it’s primarily known for its off-label use as a sleep aid due to its sedative effects. Mania If you have bipolar disorder , taking antidepressants , such as trazodone or Lexapro , can cause a manic episode, according to trazodone ’s and Lexapro ’s prescribing information.

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FDA Labelling 94

PharmExec

NOVEMBER 17, 2023

Heliyon study evaluates online information, labeling accuracy, and quantitative analysis of high peroxide content gels.

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Labelling 98

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 FDA 128

Med Ed 101

OCTOBER 29, 2023

How many times have you picked up, dispensed, or seen an auxiliary label on a medication encouraging you to avoid alcohol while taking it? It’s definitely information that could come up on a board exam at some point throughout your career! Below is a table listing the top 5 alcohol and medication interactions.

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Labelling 105

STAT

MARCH 8, 2024

Companies will sometimes give clinics this information voluntarily, along with required labeling information like mouse embryo data, instructions for use, and warnings. The Food and Drug Administration asks manufacturers for a list of materials before the media goes on the market, an FDA spokesperson told STAT.

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Labelling FDA 119

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. All medicines on the UK market must be labelled as for sale only within the UK, including in Northern Ireland.

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Packaging Labelling 105

The Checkup by Singlecare

JANUARY 10, 2025

Although gabapentin is an anticonvulsant , its often used off-label to treat restless legs syndrome (RLS) and other nerve conditions or neuropathic pain. Information on pregabalin and breastfeeding is also limited, but it also appears that it is safe and does not have adverse effects on infants. appeared first on The Checkup.

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The Checkup by Singlecare

JANUARY 20, 2025

For the past half-century, phentermine has been one of the most commonly prescribed weight loss drugs, and metformin has been one of the most popular diabetes medicationsand its also prescribed off-label for weight reduction. Thats why phentermines label lists insulin and oral hypoglycemic drugs under its interactions.

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Dosage Labelling Controlled Substances Insurance 98

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.    Continue to STAT+ to read the full story…

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FDA Communication Labelling Insurance 123

Hospital Pharmacy Europe

MARCH 26, 2024

It is likely to be safe for penicillin allergy labels (PALs) to be removed for most patients, a study from the University of Birmingham has found. Some 97% of participants labelled with PALs were shown to have no allergy. However, a large body of evidence suggests that 90-95% of PALs are inaccurate.

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Labelling Hospitals 52

The FDA Law Blog

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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FDA Labelling Dosage 104

IDStewardship

MARCH 12, 2023

Article 9: How to Harness the Power of Social Media for Quality Drug Information in Infectious Diseases: Perspectives on Behalf of the Society of Infectious Diseases Pharmacists Find it here. This articles and the previous editions are great sources of information for what is happening in antimicrobial stewardship.

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Medication Guidelines Documentation Labelling Hospitals 299

pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them. New atrial fibrillation feature.

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Documentation Labelling FDA 131

The Checkup by Singlecare

DECEMBER 30, 2024

Additionally, gabapentin is typically used as a human medicine; its prescribed off-label for dogs since it doesnt have FDA approval for them yet. Both vets urge dog owners to keep the medication out of reach of the petlike in a locked cabinet, for exampleand to follow the prescription label carefully. Vasudevan warns against opioids.

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Digital Pharmacist

OCTOBER 11, 2023

October is recognized as Health Literacy Month, a time when healthcare professionals, organizations, and communities come together to promote understanding and access to health information. Additionally, ensuring your bilingual staff is able to effectively translate medical information is crucial to patients’ understanding.

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Health and Personal Care Stores Communication Labelling 20

Pharma Marketing Network

MARCH 31, 2025

Leveraging tools that enable real-time content approval and centralized tracking can prevent outdated messaging or off-label promotion. HCPs and patients alike rely on smartphones to consume medical information, which means ad formats, landing pages, and videos must be fast, accessible, and informative.

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HIPAA Communication Labelling 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.

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Compounding Labelling Dosage Hospitals 119

pharmaphorum

SEPTEMBER 2, 2020

However the Association of the British Pharmaceutical Industry (ABPI) trade body said pharma companies are still waiting for the MHRA to provide additional technical information on other issues. The concern is that UK patients will face delays to receiving the latest medicines because of the changes to the regulatory system.

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Documentation Labelling 124

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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European Pharmaceutical Review

NOVEMBER 10, 2022

However, these techniques provide limited information on cargo distribution on/within a delivery platform. Based on fluorescently labelled antibodies and drugs, the technology offers an array of benefits to drug discovery, from characterising complex cell models of disease to understanding the molecular mechanism of drug action.

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Labelling Compounding 105

European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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FDA Documentation Method Validation Packaging 98

The Checkup by Singlecare

MARCH 18, 2025

It is often prescribed off-label (for a non-FDA-approved use) for weight loss. Mounjaro is FDA approved as a Type 2 diabetes medication and is often prescribed off-label for weight loss. The prescribing information specifically advises against using more than one of these medications at the same time. What is tirzepatide?

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Dosage FDA Labelling Insurance 52

IDStewardship

OCTOBER 14, 2024

Read all about this in the product label here. More information on ganciclovir in the label here. Also fun fact, IV SMX/TMP does not require refrigeration once mixed, so it gets a “DO NOT REFRIGERATE” sticker, at least that is more convenient. Well, maybe not. Products can impact stability.

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Compounding Labelling Packaging Hospitals 130

The FDA Law Blog

JULY 23, 2024

Information to include in IND, IDE, and marketing applications is also described within the draft guidance. For marketing applications, a summary of the EDDO information is recommended in the device description with reference to performance data and other supportive information.

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FDA Labelling 105

The Checkup by Singlecare

DECEMBER 2, 2024

Pharmaceutical options such as benzodiazepines like diazepam and antidepressants like trazodone are sometimes used off-label to treat insomnia in adults. For this reason, Dr. Dasgupta says buspirone isn’t typically a first-choice off-label (prescribed for a different purpose than its FDA-approved uses) medication for sleep.

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Dosage Labelling FDA Hospitals 72

European Pharmaceutical Review

DECEMBER 22, 2022

1 Conventional vibrational spectroscopic approaches, namely Raman spectroscopy, Fourier transform infrared (FTIR) spectroscopy, and near infrared (NIR) spectroscopy, are integral to providing chemical information about samples. The techniques reveal chemically specific information derived from vibrations within the molecules.

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Labelling 98

European Pharmaceutical Review

JULY 4, 2023

This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both. The document contains requirements and guidance for testing for bacterial endotoxins. Only Gram-negative BET using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus are covered.

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Documentation Labelling 111

The Checkup by Singlecare

MARCH 4, 2025

Although phentermine is FDA approved for short-term use only, healthcare providers sometimes prescribe it off-label (for non-FDA-approved use) for long-term weight management. You can check the manufacturer’s website for more information on insurance coverage as well as other savings options. of body weight compared to 13.7%

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Insurance Coverage Insurance FDA Labelling 52

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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FDA Documentation Communication Labelling 105

The Checkup by Singlecare

NOVEMBER 21, 2024

Adults and children weighing more than 40 kg (88 lbs) Adults, children, and infants 1 month and older Conditions treated by famotidine and pantoprazole Famotidine is FDA-approved to treat stomach ulcers and duodenal ulcers, while pantoprazole is often prescribed off-label for both ulcerative conditions. pylori) in the stomach.

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Labelling Insurance FDA Chemotherapy 98