European Pharmaceutical Review

AUGUST 23, 2024

In this blog , a summary of the key changes of relevance to primary packaging components and how West can help with the implementation will be discussed. Read more The post Are we set for the revised EU GMP Annex 1? appeared first on European Pharmaceutical Review.

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Packaging 72

The deprescribing.org Blog

JUNE 24, 2021

The CHARMER team recognised the breadth of work we as PPI members faced and developed a package of support for us, which was reviewed and updated frequently: 1. The deprescribing blog is hosted by pharmacists and postdoctoral researchers, Carina Lundby and Wade Thompson. – CHARMER PPI member. Twitter: @CHARMER_Study.

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The FDA Law Blog

JULY 22, 2024

FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.

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Packaging Labelling FDA 59

Roots Analysis

FEBRUARY 28, 2022

One of the stages that require quality assurance is packaging of the drug product, as compromised packaging could have serious consequences. The defects in the packaging of container closure system could adversely affect the sterility and stability of the drug through contamination via reactive gases, humidity and microbial ingress.

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Packaging Immunization 52

Oswald's

MARCH 11, 2025

Their distinctive lavender-colored packaging and elegant taste have made them a favorite among those who appreciate something a little different. Howards Violet Mints A truly unique vintage candy, C. Howards Violet Mints have a floral, perfumed flavor that sets them apart from anything else.

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Packaging 52

Board Vitals - Pharmacist

DECEMBER 21, 2022

Effective January 3, 2023, BoardVitals is discontinuing its CME Pro Plus package. The post An Update on BoardVitals CME Pro Plus appeared first on BoardVitals Blog. This decision aligns with our core values, primarily trust and transparency with our customers. CME Pro Plus will simply no longer exist as an option for purchase.

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Packaging 52

Roots Analysis

FEBRUARY 16, 2022

The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. [1] Thereafter, high quality standards were set for packaging and closure of such containers by the regulatory bodies. [2] Web: [link]. LinkedIn: [link]. Twitter: [link]. Medium: [link].

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Packaging Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 27, 2022

Blogs – A company is free to own a blog or engage a blog writer by way of sponsorship or consultancy fees. In the EU and UK, where direct-to-consumer promotion of POMs is prohibited, companies may not sponsor blogs that promote, or could reasonably be expected to promote, such products.

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Communication Packaging Documentation Pharmaceutical Companies 98

The FDA Law Blog

JUNE 26, 2024

eSTAR Templates As we have previously explained in our blog post here , eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions. package labeling is optional). It includes questions about the product, that when answered, reveal additional information that should be supplied with a submission.

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FDA Labelling Packaging 98

ISPE

JANUARY 10, 2023

iSpeak Blog. aseptic processing line, filling zone, stopper bowl, open primary packaging or for making aseptic connections under the protection of first air).". The Aseptic Evolution from Manual Operations to Fully Automated Robotics Solutions. Trudy Patterson. Tue, 01/10/2023 - 12:15. Richard Denk. 10 January 2023.

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Packaging Documentation 96

NF2 BioSolutions

JUNE 21, 2023

This blog has been created as a way to share real stories, ideas, positivity and even sprinkle in some science. Everyone is welcome here and warmly encouraged to join us in contributing to our community through this blog. then please contact myself, Grace Gregory, at grace@nf2biosolutions.org and we can pop it up on our blog.

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Packaging Communication Hospitals 52

Roots Analysis

MARCH 1, 2024

Examples of such technologies include DNA Taggants (a unique DNA tag used in the product / packaging that can be scanned using a designated instrument / equipment), invisible printing technologies, digital watermark technologies and hidden markers / print technologies. Such technologies have been shown to have highly secured features.

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Packaging Labelling 52

ISPE

MARCH 24, 2023

When surveyed, 92% (35/38) of respondents indicated they are willing to take additional actions in handling the single-use assemblies and/or packaging to allow for better end of life management. Packaging sorting is a simpler action that could be more easily adopted. Supplier optimizing packaging/reducing packaging waste.

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Packaging 52

The FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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FDA Documentation Packaging Communication 75

The FDA Law Blog

FEBRUARY 16, 2023

We previously blogged on FDA’s September 2022 guidance exempting and excluding specific naloxone transactions (e.g., Participants were allowed to review the DFL and packaging for an “unlimited” period which is not representative of a high-risk scenario. Two user groups did not include at least 30% limited literacy participants.

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Labelling Packaging FDA 64

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

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Packaging Dosage 52

The FDA Law Blog

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. For any major changes, additional time will be granted between the release of the implementation package and production deployment. User facilities are not required, but have been encouraged, to submit MDRs electronically.

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Packaging FDA Communication 59

Pharma Marketing Network

AUGUST 9, 2023

In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

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Packaging Labelling Communication Pharmaceutical Companies 52

Omnicell

JANUARY 10, 2023

The XR2 system was instrumental in helping the hospital pharmacy shift from purchasing bulk medications to manufacturer unit-dose packaging forms. The cost difference was negligible and offset by eliminating consumable costs and reallocating packaging labor.

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Hospitals Omnicell Inventory Control Packaging 52

Fuld

APRIL 15, 2021

In just three years, Amazon has put together a package of leading-edge services that have the potential to revolutionize the US healthcare market. Five months later in June, it announced the $753 million acquisition of PillPack and its move into the drug supply chain with mail order pouch packaging services. .

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Health and Personal Care Stores Cerner Packaging Customer Service 96

The FDA Law Blog

NOVEMBER 7, 2022

Kirschenbaum — On Friday, November 4, CMS finalized a rule to implement mandatory rebates (called “refunds”) for discarded amounts of separately paid Medicare Part B single-source drugs packaged in single-dose or single-use containers. The requirement to use a JW modifier for discarded amounts beginning on January 1, 2023 remains in place.

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Packaging 59

The FDA Law Blog

SEPTEMBER 24, 2024

Before FDA even asked, we had been considering an HPM FDA Law Blog post on this subject. The appeal of distilling down the extensive process that goes into the decision to approve an application into a single package is easy to see, and some may be interested in only the ultimate distillation – an approval is issued or not.

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Documentation FDA Packaging 59

The FDA Law Blog

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

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FDA Packaging 52

ISPE

SEPTEMBER 8, 2022

iSpeak Blog. The patient-centric strategy further explores how demographics and epidemiology of the disease state can be impacted by using an intelligent packaging design, the adoption of decentralized clinical trial designs, and the integration of underserved communities. The Next Horizon for Therapy Innovations. Trudy Patterson.

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Packaging FDA 93

The FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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FDA Packaging Communication 64

ISPE

NOVEMBER 29, 2022

iSpeak Blog. Embracing the diversity of packaging materials on a multi-purpose fill/finish line for many different kinds of ready-to-use containers. Aseptic Manufacturing Case Studies Preview. Trudy Patterson. Tue, 11/29/2022 - 13:31. Aseptic Manufacturing Case Studies Preview. Klaus Ullherr. Weseli, CPIP. 29 November 2022.

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The FDA Law Blog

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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FDA Labelling Packaging Documentation 59

Aureus Medical Group

AUGUST 29, 2022

They can help you with information on traveler benefits , pay packages, reimbursements, bonuses , housing, travel arrangements, and more! . Traveler FAQ’s Traveler Tax Info Aureus Medical Blog Page State Licensing Resources Traveling with Aureus Medical Timeline. Helpful Traveler Resources. Let’s get started!

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Packaging 52

ISPE

JANUARY 24, 2023

Read More Reining in Consumption for Sustainable Manufacturing The word “sustainability” is both overused and abused: We hear about sustainable development in a sustainable economy that uses sustainable packaging for a sustainable future.

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Packaging Pharmaceutical Companies Pharmaceutical Companies 52

Omnicell

JANUARY 10, 2023

Stephanie Gallagher, PharmD, MBA Senior Clinical Product Marketing Manager, Omnicell Imagine if Amazon lost one out of every 10 packages. DISCLAIMER The views and opinions expressed in this blog are those of the authors and do not necessarily reflect the official policy or position of any other agency, organization, employer or company.

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Sterile Compounds Compounding Omnicell Documentation 52

ISPE

NOVEMBER 22, 2022

iSpeak Blog. From aseptic manufacturing, process development, primary packaging selection to finished goods – you will be able to gain a lot more technical experiences by speaking to colleagues in the industry. Top 5 Reasons to Attend the 2023 ISPE Aseptic Conference. Trudy Patterson. Tue, 11/22/2022 - 11:50. 22 November 2022.

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Compounding Packaging Dosage Vaccines 98

ISPE

MARCH 14, 2023

The survey was distributed via an email communications to ISPE members, a blog on ISPE’s website, and LinkedIn postings. In this two-part blog series, we first spotlight a summary of the survey findings of the current status for handling single-use items once they have completed their mission.

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Packaging Communication 98

Omnicell

JANUARY 10, 2023

By increasing efficiencies with XR2, optimizing processes, reducing packaging requirements – all of that will allow us to reallocate resources to patient programs. The monthly subscription meant not having a large capital investment, which helped accelerate the approval process.

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Omnicell Packaging Patient Care 52

Aureus Medical Group

OCTOBER 19, 2022

Aureus Medical Group travelers are covered from day one with a comprehensive perks and benefits package that includes: Low-cost, day-one health, vision, and dental. Every agency is different, so discussing your plan’s specifics with your recruiter is best. Unlimited loyalty and referral bonuses. 401k with company match. Updated Oct.

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Packaging Communication Insurance Immunization 98

The FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Once the device is required to bear a UDI, any NHRIC and NDC codes will no longer be permitted on the device label or device packaging.

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Packaging Labelling FDA Documentation 45

Roots Analysis

DECEMBER 8, 2021

In order to devise a framework to determine / compare the prices of bio-preservation media, six relevant parameters were taken into consideration, namely, preservation condition, type of serum, type of biological sample, packaging volume, packaging format, and area of application.

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Packaging 52

The FDA Law Blog

NOVEMBER 14, 2022

Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). That said, the guidance will be a helpful reference for companies that are not sure whether they are subject to the OMUFA facility fees, whether there any exceptions, how much they have to pay, when they need to pay, etc.

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FDA Packaging Labelling Dosage 52