RX Note

JULY 2, 2023

Introduction American Hospital Formulary Service Drug Information (AHFS DI) from the American Society of Health-System Pharmacists (ASHP) is a comprehensive source of drug information for health professionals with therapeutic guidelines and off-label uses.

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Labelling Hospitals 52

RX Note

JULY 29, 2023

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

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Labelling Dosage Immunity Immunization 40

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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Labelling Biosimilars Adverse Reactions Dosage 62

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

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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Pharma Leaders

MAY 15, 2023

Manufacturers of amphetamine and methylphenidate products, a class of stimulant medications used to treat ADHD and other disorders, must update their labeling and prescribing information to “clearly inform” patients, caregivers and healthcare professionals risks associated with these medications.

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Medication Labelling Labelling 52

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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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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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

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

Pharmaceutical Technology

MARCH 16, 2023

Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz.

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Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

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Labelling Packaging Documentation Dosage 52

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

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Labelling Packaging 40

PioneerRx

DECEMBER 14, 2022

Returning unclaimed prescriptions to inventory requires precautionary measures to ensure patient safety and protect personal information…

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Labelling 52

pharmaphorum

OCTOBER 5, 2020

PRISYM ID appoints Software Delivery Manager to oversee team developing new clinical labeling solutions . . regulated content and label management?solutions, For more information:? . The post PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team appeared first on. Wokingham, United Kingdom —?30?September?2020?—

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Labelling 52

Pharmaceutical Technology

MAY 12, 2023

As the next step in the FDA’s efforts to reduce prescription drug deaths , the agency is requiring updates to the boxed warning and other information for attention deficit hyperactivity disorder (ADHD) prescription stimulants. Prescription stimulants are used to treat ADHD, narcolepsy, and binge-eating disorder.

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Labelling Patient Counseling Communication 59

pharmaphorum

OCTOBER 7, 2021

A recent Accenture survey found that a majority of HCPs (82%) think pharma companies have increased the value of what they communicate in the last 18 months, delivering not just product information but also support that meets pressing needs, such as education on how to better treat patients remotely. About the interviewee.

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Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 96

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

pharmaphorum

JANUARY 28, 2021

For PRISYM ID client RxSource , a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor companies to get everything set up for a clinical trial within a week, including packaging and labeling. The post RxSource optimizes clinical labeling process with PRISYM 360 cloud-based solution appeared first on.

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Labelling Packaging Vaccines 52

FDA Law Blog: Biosimilars

MAY 23, 2023

We previously noted that “ the skinny label may be dead ” and, while we still can’t be sure if it’s truly gone (but not forgotten), we now know that the Supreme Court won’t hear this case at this time. Generic manufacturers, as they always have before, must review the patents and carve-out information in accordance with that patent.

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Labelling 40

Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. A drug’s “label” can include its inner or outer labels, a package insert, or its product monograph ( PM ). Guidelines for electronic labelling.

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Labelling Documentation Packaging 40

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

FEBRUARY 4, 2021

We have to listen even harder to understand how companies visualize their operating practices going forward but the great news is, I know PRISYM ID is positioned better than anyone to respond and deliver the regulated labeling and content management solutions they need.

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Labelling 52

FDA Law Blog: Biosimilars

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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Labelling Biosimilars Drug Pricing Dosage 104

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

PharmaShots

JUNE 16, 2023

Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg Shots: The US FDA approved an updated label for mavacamten (2.5/5/10/15mg For more information connect with us at connect@pharmashots.com Your go-to media platform for customized news ranging for multiple indications.

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Labelling 40

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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Pharma Packaging Solutions

JULY 17, 2023

Here is a brief overview of biologics packaging and labeling requirements according to the Code of Federal Regulations. Licensing: The CFR states that all packaging and labeling must be performed in a properly licensed facility. Label Legibility: All labeling on biological packaging must be legible.

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Packaging Labelling 52

FDA Law Blog: Biosimilars

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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Biosimilars Labelling Communication 59

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 97

Quality Matters

MARCH 8, 2024

1 Social media and influencers may include misleading information and sweeping health claims to sell a product without considering one of the most important elements of any supplement – the quality of ingredients. Further, the proclaimed health benefits found on an unverified supplement’s label are not necessarily true or accurate.

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Labelling 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

PharmaTech

JANUARY 16, 2023

The guidance provides examples of required and recommended information in the Dosage and Administration section.

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Pharma Packaging Solutions

NOVEMBER 8, 2023

Vial and Ampoule Labeling Many biologics are available primarily in liquid form. Tjoapack handles crucial secondary packaging jobs like vial and ampoule labeling. Labels provide consumers with important information such as instructions and warnings.

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LifeProNow

JULY 14, 2023

For approval of a product for use in the nonprescription setting, the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.

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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.

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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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