Express Pharma

MARCH 12, 2025

It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin.

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ID Stewardship

JANUARY 13, 2025

BCIDP UNDER CONSTRUCTION Article PostedXXX Sulopenem etzadroxil and probenecid (Orlynvah) was recently approved in October 2024 for the treatment of uncomplicated urinary tract infections (uUTI) caused by Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis. 2024 Nov 2:S1198-743X(24)00507- X. Orlynvah [package insert].

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European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

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Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. They may be submitted here and are due by January 5, 2024 Read the full statement here. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber.

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LifeProNow

MARCH 10, 2023

billion as part of the president’s fiscal year (FY) 2024 budget. The FY 2024 request, which covers the period from Oct. 30, 2024, includes new efforts for high priority program areas. million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight.

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GMPSOP

MARCH 30, 2024

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Different products should not be packaged in proximity unless physical segregation exists. Please look at the labeling operation in the picture below.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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Express Pharma

DECEMBER 24, 2024

The impact of packaging is felt only when it does not do its job and therefore pharmaceutical companies have traditionally invested quite a bit on product packs, also using them as part of their branding strategy. sq mm of material – there is more than 20 per cent reduction of packaging material. per cent CAGR. Shivshankar S.R,

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

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RX Note

DECEMBER 25, 2024

Strategies for sodium reduction include Make reading food labels a habit. meats, fruits and vegetables) rather than their packaged counterparts. WebMD - Celtic Salt: What You Should Know, 2024 Should you use iodized salt?, When available, buy low-sodium, reduced-sodium or no-sodium versions of foods (e.g.

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ID Stewardship

OCTOBER 14, 2024

BCPS, BCIDP Article Posted October 2024, First Released in the October 2024 IDstewardship Newsletter 1. Read all about this in the product label here. More information on ganciclovir in the label here. The process is detailed in the package insert here. Authored By: Timothy P. Gauthier, Pharm.D., Well, maybe not.

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Labelling Compounding Packaging Hospitals 52

Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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Packaging Labelling 52

LifeProNow

JANUARY 18, 2025

Data collected through the second quarter of 2024 and presented at the European Society for Medical Oncology (ESMO) 2024 Congress as alate-breaking oral presentationshowed an 83.5 TAR-200 is an investigational intravesical drug releasing system designed to provide sustained local delivery of gemcitabine into the bladder.

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Express Pharma

MAY 6, 2024

The event brought together over 330 professionals from across the industry’s value chain Pharmaceutical Manufacturing and Packaging Congress (PHARMAP 2024) was held in Amsterdam, Netherlands on April 22-23, 2024. Among the attendees, contract manufacturing organisations, service providers and experts were present.

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Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 105

Pharmaceutical Technology

JUNE 13, 2025

The US Food and Drug Administration (FDA) has approved the label expansion of AbbVie’s Mavyret (glecaprevir/pibrentasvir) for treating adults and paediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection. Credit: © AbbVie Inc. All rights reserved.

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Labelling Communication Hospitals Vaccines 52

PharmaShots

MARCH 1, 2023

osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss The submission was based on the comprehensive analytical and clinical data package, incl.

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Biosimilars Packaging Labelling 40

Express Pharma

JUNE 28, 2024

With a focus on redefining the pharmaceutical industry in the post-COVID era, PharmaLytica 2024 offered a platform for stakeholders to engage in discussions covering the full spectrum of pharma machinery and packaging, lab analytical and cleanroom solutions, and pharmaceutical ingredients. We exported $ 27.8

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Packaging Biosimilars Labelling Vaccines 105

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 7] A recent report from 2024 found that fluoride exposure is associated with lower IQ in children, which has brought the issue of fluoridation front and center again (the U.S.

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PharmaTech

JUNE 6, 2025

In these instances, gas phase sequencing of purified peptides (also known as Edman sequencing) can be performed to sequentially identify amino acids based on their chromatographic elution positions following specific, sequential chemical labeling. MS provides mass information allowing identification of N-glycan compositions.

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Pharmaceutical Technology

JUNE 16, 2025

At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.

Labelling 52

Labelling Communication Hospitals Vaccines 52

Pharmaceutical Technology

JUNE 16, 2025

By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. Give your business an edge with our leading industry insights.

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Insurance Coverage and Processing Communication Hospitals Vaccines 98

PharmaTech

JUNE 12, 2025

The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections. Implications of RFK Jr.’s

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PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

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Immunization Immunity Vaccines Health and Personal Care Stores 40

Pharmaceutical Technology

JUNE 13, 2025

Moderna’s vaccine, known under the brand name mRESVIA, became the first non-Covid-19 messenger RNA-based (mRNA) vaccine to be approved in the US in May 2024. Moderna gains on Pfizer The label expansion sees Moderna catch up with Pfizer, which already has an RSV vaccine approved for adults aged 18 years and over.

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Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.

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European Pharmaceutical Review

JANUARY 20, 2025

Sustainable practises in healthcare benefit everyone ePI represents a step towards reducing the environmental footprint of pharmaceutical supply chains by eliminating paper leaflets and reducing packaging size. Several AstraZeneca markets have already demonstrated the benefits a transition to ePI could bring. Cited 2024Aug]. Data on File.

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Pharmacy Times

JUNE 5, 2025

Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 1-3 Detect-A-Dose Lid Label Covers. 1-3 Detect-A-Dose Lid Label Covers. Pharmacists must adapt to new tools, ensuring safe medication distribution through improved literacy and teamwork.

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Pharmacy Technician Packaging Labelling Immunization 26

Express Pharma

APRIL 25, 2025

Paying attention to details at every step, from labeling, packaging, and storage to transportation, ensures a supply chain where quality and standards are maintained. Industry standards have evolved to incorporate temperature-controlled packaging leveraging advanced technology.

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