Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

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The FDA Law Blog

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.

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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. By Li Jie of ClinsChain

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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. By Li Jie of ClinsChain

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Pharmaceutical Technology

JANUARY 15, 2023

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children.

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Labelling Packaging FDA Communication 52

The Checkup by Singlecare

MAY 4, 2023

Understanding the drug label Much of the information you need to know is printed on the label of your medicine. OTC meds usually have a “Drug Facts” label that lists important information. In addition, prescription drugs may have labels with similar information. Medicines taken by injection should be premeasured.

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ISPE

OCTOBER 28, 2022

Glass ampoules, as illustrated in Figure 1, offer protection against air and contaminations and are widely used as the primary packaging for pharmaceutical drugs. The foundation for every successful AI project is to build a database that consists of high-quality images and high-quality data labels. Project Scope. Proof of Value.

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The FDA Law Blog

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

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Pharmaceutical Technology

JUNE 20, 2023

It plans to work with the FDA to plan new analyses and further develop a new application package. Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164). Please check your email to download the Report.

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ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Currently, it takes time and/or communications (e.g.,

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DiversifyRx

JULY 11, 2024

This is no big deal; you need to make sure that when you receive the product from your trading partner, it includes the product identifier (NDC (or GTIN), Serial Number, Lot Number, Expiration Date) in a human as well as machine-readable format (2D barcode) on the manufacturer label.

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ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.

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European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

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The Checkup by Singlecare

JANUARY 26, 2023

If you’ve worked in a community pharmacy, you’ve likely had the same frustrating conversations about prescription labels over and over. Due to variability in health literacy, studies show that Americans’ level of understanding of prescription label instructions ranges from 53% to 89%.

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The Checkup by Singlecare

MARCH 16, 2023

This includes counting, measuring, and packaging medications, as well as labeling and organizing them for distribution. “They work closely with pharmacists to ensure that medications are prepared and dispensed accurately and safely,” he says. RELATED: Ways to prevent common pharmacy errors 7.

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Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Hospital Pharmacy Europe

APRIL 14, 2025

However, issues arose due to a lack of PAAP, insufficient communication between or within services and families, failure to recognise child deterioration, and treatment delays. Learnings from the CDOPs showed that allergy symptoms were not always communicated to healthcare professionals.

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Pharmaceutical Technology

FEBRUARY 27, 2023

Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. You may unsubscribe from these ISPE communications at any time.

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The Checkup by Singlecare

MARCH 4, 2024

It is also used off-label for other forms of dementia. Product labels acknowledge the opposing mechanisms and recommend avoidance of the combination whenever possible. The manufacturer of dexamethasone products recommends withdrawal of anticholinergic agents at least 24 hours before initiation of steroid therapy in its packaging.

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The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. Precautions Do not take more than the recommended dose on the label. The herb itself can be poisonous if ingested.

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The FDA Law Blog

MARCH 30, 2025

Encouraging Transparency : FDA is working closely with manufacturers to ensure clearer labeling and increased transparency regarding ingredients and nutritional information on formula packaging.

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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. Moreover, fostering a culture of transparency and open communication will help build trust and encourage widespread adoption.

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