pharmaphorum

JANUARY 9, 2025

Pharma groups have called for EU adoption of electronic product information (ePI) to take place within four years in a new position paper.

Packaging 105

Packaging 105

STAT

DECEMBER 1, 2022

At a time when many Americans are clamoring for more transparency into prescription drug pricing, one key provider of that data is making it harder to access the information. This includes details such as separate doses and packaging on both current and historical prices.

Packaging 96

Packaging 96

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

The FDA Law Blog

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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FDA Labelling Packaging 98

STAT

JUNE 4, 2024

But a year ago, Zynex informed her that the Tufts plan had never paid, and instead, those bubble-wrapped packages were going to cost her almost $1,000. Before she bought the electrical stimulation unit, Zynex assured her the supplies would be covered by Tufts Health Plan, her insurance company.

Packaging 141

Packaging Insurance 141

The FDA Law Blog

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. Hyman, Phelps & McNamara, P.Cs

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Packaging Documentation Compounding 59

STAT

JULY 23, 2024

The committee found evidence of PBMs sharing patient information among affiliated companies for the specific and anticompetitive purpose of steering patients to pharmacies a PBM owns. Continue to STAT+ to read the full story…

Packaging 127

Packaging 127

Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

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Packaging Documentation Communication Labelling 52

European Pharmaceutical Review

JANUARY 10, 2023

In 2024, Pharmapack Europe, the two-day exhibition and conference for pharma’s drug delivery and packaging industry will introduce two brand new zones to the flagship event. Bio packaging zone . Pharmapack’s bio packaging zone builds on its long history of being at the forefront of innovations in biological drug delivery.

Packaging 96

Packaging 96

IDStewardship

NOVEMBER 29, 2023

BCPS, BCIDP Article Posted 1 December 2023 Podcasting has emerged as an incredible way to reach a global audience and discuss scientific information. They are very valuable because they provide information in a way that is readily accessible. Interviewee: Luis Plaza Interviewer: Timothy P. Gauthier, Pharm.D.,

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Patient Care Hospitals Packaging Communication 246

Roots Analysis

AUGUST 14, 2024

Packaging is the process of enclosing a product in a container in order to protect and store it. In the pharmaceutical industry, packaging plays a crucial role in ensuring the strength and integrity of a product. Further, the type of raw material utilized for packaging highly depends on the type of product / drug to be enclosed.

Packaging 40

Packaging Dosage Labelling 40

ISPE

OCTOBER 1, 2022

Module Type Package: Turning Visionary Concepts into Reality. Module Type Package: Turning Visionary Concepts into Reality. The Module Type Package (MTP) approach designates each module with a digital description, enabling flexible module connection and orchestration. Trudy Patterson. Sat, 10/01/2022 - 06:00. Sponsored Content.

Packaging 52

Packaging Communication 52

Pharmaceutical Technology

JUNE 14, 2023

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

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Packaging Labelling 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers. Trends in clinical packaging.

Packaging 40

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 40

ISPE

MARCH 9, 2023

The following CoP’s will be represented: Advanced Therapy Medicinal Products (ATMPs) Biotechnology Commissioning & Qualification Combination Products Containment Critical Utilities Disposables/Single-Use Technologies GAMP ® Investigational Products Oral Solid Dosage Pharma 4.0

Packaging 52

Packaging Dosage 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Pharmaceutical packaging formats and materials.

Packaging 40

Packaging Labelling Documentation Pharmaceutical Companies 40

The Checkup by Singlecare

JANUARY 9, 2025

Youll know your semaglutide isnt compounded if you spot the brand name on the packaging and information leaflet. Its also packaged differently, which can be an easy identifier. Brand-name semaglutide comes in two formspre-filled injectable pens (Ozempic and Wegovy) and oral tablets (Rybelsus).

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Compounding Compounding Pharmacies FDA Sterile Compounds 104

Hospital Pharmacy Europe

MARCH 31, 2025

Their insights into the supply chain allow them to identify inefficiencies and advocate for more sustainable practices, such as reducing excess packaging and improving storage conditions. J Am Med Inform Assoc 2024;31(3):73245. Self-reported digital literacy of the pharmacy workforce in North East Scotland. 8 Alowais M et al.

Hospitals 52

Hospitals Packaging Patient Care 52

STAT

JULY 27, 2023

It’s not every day that a marketing team is tasked with designing the branding and packaging of the first over-the-counter birth control pill to be sold in the U.S.

Packaging 97

Packaging Communication FDA 97

STAT

APRIL 26, 2024

The goal is for the House to pass the bill before the July 4 recess, setting it up to be included in a year-end must-pass legislative package. national security if they give the Chinese government access to sensitive health information about Americans.

Packaging 105

Packaging 105

Pharmaceutical Technology

MAY 2, 2023

Datwyler is a leading provider of parenteral packaging components and is helping the industry put quality first through the invention of the FirstLine® manufacturing standard. It also explores the causes of contamination and how parenteral packaging – one potential source – can be adapted to minimise the risk.

Packaging 52

Packaging Communication 52

European Pharmaceutical Review

AUGUST 31, 2023

To cope with the growing demand for production flexibility and agility, IMA Group is structured according to highly specialised pharmaceutical divisions that concentrate on specific processing and packaging areas. Isolation technologies and other containment solutions are also part of our expertise.

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Vaccines Packaging Pharmaceutical Companies Pharmaceutical Companies 104

European Pharmaceutical Review

AUGUST 23, 2023

It offers information for manufacturers of new and established biopharmaceuticals on ways to incorporate them into their quality testing. A separate informational chapter was developed to expand on the use, validation, and comparability of endotoxin tests based on recombinantly derived substances.

Packaging 98

Packaging 98

ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities.

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Adverse Reactions Packaging Communication Labelling 52

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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FDA Documentation Method Validation Packaging 98

STAT

JULY 11, 2024

This calls for celebration with a cup of stimulation, and we are opening a new package of blueberry muffin for the occasion. The agency sent the drugmaker a complete response letter, saying it needs more information on the drug’s manufacturing process, as well as more data on how well it performs in people with type 1 diabetes.

Packaging 92

Packaging FDA 92

pharmaphorum

JANUARY 12, 2022

The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen that is used for displaying patient information and data, as well as analysing and sharing clinical results.

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Hospitals Patient Care Packaging Documentation 128

European Pharmaceutical Review

JUNE 4, 2024

IMA Safe Specialised in primary and secondary packaging, IMA Safe creates blister-packaging machines, capsule and tablet counters, sachet and stick-packaging machines, tube fillers and cartoners. End-of-line solutions, from robotics, handling, overwrapping to case-packing and palletising are provided by the IMA EOL hub.

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Packaging Customer Service Labelling Dosage 95

pharmaphorum

NOVEMBER 24, 2020

The elements of its digital health portfolio included integrated care management unit Thrasys – whose SyntraNet health information exchange platform is used to organise patient health records and workflows.

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Packaging Compounding Insurance Patient Care 138

European Pharmaceutical Review

JANUARY 23, 2023

Through EMA’s engagement with its stakeholders, the Medicines Shortages Steering Group has received up-to-date information from community pharmacists on the situation in pharmacies across the EU. Based on current information from companies and stakeholders, it is expected that the situation will improve in the coming months.

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Packaging Compounding Communication Labelling 98

European Pharmaceutical Review

JULY 25, 2022

These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. As a result, the development of advanced packaging-level tokens has led to watermarking techniques; invisible, encoded data that requires specialist verification software. Supply-chain visibility.

Packaging 104

Packaging 104

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. These standardised documents provide meticulously curated and scientifically approved information. Exploring the benefits of ePI ePI offers advantages, notably swift access to updated medication information.

Packaging 98

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 98

European Pharmaceutical Review

JULY 27, 2023

With this innovation, researchers can package biological materials into tablets that can be stored on a shelf at room temperature. How the method was tested The research team demonstrated that the cell’s machinery capable of decoding genetic information into making RNA and proteins can be stored in a solid-state.

Packaging 98

Packaging 98

European Pharmaceutical Review

MARCH 21, 2024

Insights obtained from patients are used to better understand the impact of the disease on their daily life, and to carefully design all stages of drug product manufacture: from clinical studies to package design. What are the three main factors to consider when looking to develop patient-centric drug products?

Packaging 110

Packaging 110

STAT

AUGUST 21, 2023

At a meeting at Cold Spring Harbor Laboratory that drew more than 400 of the field’s top scientists, the company shared more detailed information about studies it has conducted to assess the risks that renegade CRISPR components could be getting into an egg or sperm.

Packaging 98

Packaging 98

The FDA Law Blog

AUGUST 27, 2023

the ability to associate the saleable return product with the transaction information/statement with the particular product). the ability to associate the saleable return product with the transaction information/statement with the particular product). Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.

FDA 52

FDA Packaging 52

IDStewardship

OCTOBER 14, 2024

More information on ganciclovir in the label here. The process is detailed in the package insert here. Depending on how an IV room pharmacy is set up, certain equipment may have to be turned on, left to run for a time, cleaned, then a dose can be prepared. Products can impact stability. Have another one?

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Compounding Labelling Packaging Hospitals 130