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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Labelling Communication 323

The Pharmacist

SEPTEMBER 29, 2023

The warning comes from the Royal Pharmaceutical Society (RPS) as it launches a new checklist for pharmacists to help inform conversations with patients about penicillin allergy. […] The post Millions wrongly labelled allergic to penicillin, warns RPS appeared first on The Pharmacist.

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Labelling Hospitals 115

Pharmaceutical Technology

JUNE 25, 2025

The updated label for GE HealthCare’s positron emission tomography (PET) imaging agent Vizamyl (flutemetamol F 18 injection) now includes quantification of amyloid in the brain, meaning patients taking an anti-amyloid therapy can be monitored for the drug’s effectiveness. Don’t let policy changes catch you off guard.

Labelling 52

Labelling Packaging Communication Hospitals 52

World Pharma News

NOVEMBER 17, 2023

The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). The product information of a medicine includes its summary of product characteristics, labelling and package leaflet.

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Packaging Labelling 107

The Pharmacist

JULY 10, 2023

A batch of Labetalol 200mg tablets has been recalled as they are incorrectly labelled as 100mg tablets on the foil blister packaging. But the Medicines Healthcare Products Regulatory Agency (MHRA) said that the actual tablets were 200g strength, consistent with the information on the outside of the box.

Dosage 98

Dosage Labelling Packaging 98

The Pharmacist

APRIL 16, 2024

Various formats for the e-labelling of medicines may hinder patient access to information, a new report has warned.

Labelling 85

Labelling 85

Express Pharma

DECEMBER 30, 2024

In the case of both, PAN-40 and Augmentin 625 Duo, the statement divulges, The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. It also features the replies from the drug makers whose drugs were flagged, without naming them.

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Labelling 105

Drug Patent Watch

MARCH 5, 2025

Pharmaceutical drug names are more than just a label - they're a carefully crafted code that conveys essential information about the medication. The Science of Pharmaceutical Drug Naming: A Key Takeaway Pharmaceutical drug names are a carefully crafted code that conveys essential information about the medication.

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Pharmaceutical Companies Pharmaceutical Companies Dosage Labelling 87

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Loose Ends IDEs.

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Documentation Labelling Communication 105

Pharmaceutical Technology

MAY 16, 2023

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.

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Labelling 98

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 Hospitals 105

STAT

JULY 26, 2024

Novo plans to add the prescribing information on the Wegovy label in the EU within about one month. Food and Drug Administration approved the drug for prevention of cardiovascular events in people with obesity earlier this year. Continue to STAT+ to read the full story…

Labelling 268

Labelling Diabetes 268

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 98

Drug Patent Watch

APRIL 8, 2025

This means ensuring that generic manufacturers adhere to the same quality control standards as brand-name companies, and that patients have access to accurate and reliable information about the medications they're taking. So, what can we do to ensure patient safety with generic drugs?

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Labelling 67

STAT

SEPTEMBER 13, 2024

One doctor said he thinks the company wants to discourage using the drugs for unapproved purposes, a practice called off-label prescribing, which is legal and accepted in American medicine. They didn’t get any money for the drugs, which is paid to pharmacies. and Mike Braun (R., would authorize the U.S.

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Medical Records Labelling Diabetes Drug Pricing 247

FDA Law Blog: Biosimilars

JUNE 26, 2024

Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.

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Labelling Packaging 98

ALiEM - Pharm Pearls

APRIL 14, 2023

Highlighted Quality Posts: Procedures Site Article Author Date Label Rebel EM Intra Articular Lidocaine vs Sedation in Shoulder Reductions Nordia Matthews, MD 30 Jan 2023 AIR EM Docs Video Laryngoscopy in the ED Cameron Jones, MD 8 Aug 2022 AIR First 10 EM Lacerations: Does closure technique matter? Please go to the above link.

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Labelling 246

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).

Labelling 64

Labelling 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.

Packaging 52

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 52

PharmaShots

JUNE 12, 2025

Shots: The US FDA has approved label expansion of Mavyret (glecaprevir/pibrentasvir) to treat pts (≥3yrs.) with acute or chronic HCV infection, without cirrhosis or with compensated cirrhosis Label expansion was supported by P-III ( M20-350 ) trial assessing Mavyret (QD, PO) in 286 treatment-naïve adults with acute HCV infection for 8wks. &

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Labelling 59

FDA Law Blog: Biosimilars

JUNE 2, 2025

RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Indeed, FDA states, the existence of a certification program alone would not relieve manufacturers from their responsibilities to ensure that their labeling and distribution practices for RUO/IUO products are consistent with the products RUO/IUO label.

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Labelling 64

Pharma Packaging Solutions

NOVEMBER 1, 2024

In recent years, the pharmaceutical landscape has witnessed a considerable adjustemnt towards private label medications. Once relegated to the sidelines, private label pharmaceuticals are now gaining traction, reshaping the industry’s consumer preferences. Experience the benefits of our private label Tjoapack.

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Labelling Packaging 52

PharmaShots

JUNE 11, 2025

For more information connect with us at connect@pharmashots.com The post Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM appeared first on PharmaShots. Your go-to media platform for customized news ranging for multiple indications.

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Labelling 59

Express Pharma

JUNE 26, 2023

Nutrify Genie combines information, speed, accuracy, and quality in the design of new products. To address this need, Nutrify Genie combines information, speed, accuracy, and quality in the design of new products. This creates a strong need to ensure evidence-based safety and efficacy.

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Labelling Compounding 122

ALiEM - Pharm Pearls

JULY 20, 2023

Highlighted Quality Posts: Infectious Disease Site Article Author Date Label SGEM Lumbar punctures in febrile infants with positive urinalysis – it’s just overkill Dennis Ren, MD December 31, 2022 AIR EMDocs Bacterial Meningitis Mounir Contreras Cejin, MD January 28, 2023 HM ALiEM The Febrile Infant Corey Ziemba, MD, Justin Hacnik, MD and J.D.

Labelling 188

Labelling 188

EMCrit Project

JUNE 16, 2025

14 October 2024 Volume 5 – 2024 | [link] Additional New Information You Need an EMCrit Membership to see this content. intensivist, CCRN, etc.) Δ Label {} [+] Full Name* We may delete without a full, true name Email* What's Your Job?* Pain Res., Login here if you already have one. Your Job (i.e. Your Job (i.e.

Labelling 108

Labelling Hospitals Packaging Documentation 108

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 Drug Development 128

PharmExec

NOVEMBER 17, 2023

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

Labelling 98

Labelling 98

Express Pharma

JUNE 18, 2025

The product database was developed to provide direct online access to all registration-relevant information. Production departments assess filling-line compatibility and labelling formats. It also features sustainable options made from 100 per cent recycled PET and sugar cane.

Packaging 63

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 63

ALiEM - Pharm Pearls

NOVEMBER 3, 2023

2023.02.011 , PMID 36967275 Author information Chris Belcher, MD Editor, ALiEM AIR Series Assistant Professor and Assistant Program Director Department of Emergency Medicine University of Kentucky College of Medicine | Twitter | The post ALiEM AIR Series | Trauma 2023 Module appeared first on ALiEM. Please go to the above link.

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Labelling 211

RX Note

JULY 7, 2025

It provides quick information on indications, dosage, availability and prescribing category. Logging in with intranet pharmacy account unlocks additional information, such as official circulars and related forms. Similarly, the off-label uses can be clearly highlighted too. The app also features a common medical calculator.

Health and Personal Care Stores 52

Health and Personal Care Stores Formulary Information Hospitals Dosage 52

Express Pharma

MARCH 20, 2025

Prescribing Information for India. 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. References: Mounjaro. Tirzepatide Once Weekly for the Treatment of Obesity.

Diabetes 101

Diabetes Labelling Communication 101

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.

Labelling 105

Labelling 105

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 Drug Development Documentation 52

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

PharmaShots

JUNE 11, 2025

in label Ref: Nuvationbio | Image: Nuvationbio | Press Release Related News:- BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors PharmaShots! .); due to TRUST’s single-arm design, mPFS was not incl.

Labelling 59

Labelling 59

RX Note

DECEMBER 25, 2024

Nevertheless, for drugs available in Malaysia, you should be able to find the necessary information in MIMS Malaysia NPRA Quest 3+ Product Search. Off label use information can be found here too. NOTE: Both Martindale The Complete Drug Reference and Lexicomp have limited list of international brand name, which vary by country.

Biosimilars 52

Biosimilars Community Pharmacies Labelling Communication 52