Pharmaceutical Technology

JUNE 19, 2023

It is critical to understand the supply chain, plan your packaging, storage and distribution lanes, then test the entire process before patient shipments go live. Products are stored and packaged in a dedicated suite by a dedicated team,” explains MacNeir. The requirements When handling personalised medicines, time is of the essence.

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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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DiversifyRx

NOVEMBER 24, 2023

This tracking involves the use of unique product identifiers, such as serial numbers and barcodes, on drug packaging to track their movement. Serialization Serialization is the process of assigning a unique identifier, typically a serial number, to each prescription drug package. The DSCSA aims to streamline this recall process.

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The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.

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Pharma Marketing Network

DECEMBER 4, 2024

Tools like telehealth platforms, mobile apps, and digital detailing enable seamless communication with HCPs and patients. Stay updated with regulations from the FDA, EMA, and other governing bodies to avoid costly penalties. Highlight your commitment to eco-friendly practices, from reducing packaging waste to sourcing ethically.

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Viseven

AUGUST 15, 2024

For instance, the FDA’s requirement for Patient Perspectives in drug reviews has made patient engagement crucial for approvals and reimbursements. Engagement can lead to improvements in drug delivery methods, packaging designs, and support services that enhance the overall patient experience.

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ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. defines a service-oriented architecture (SOA) where application components provide services to the other components through a communication protocol over a network. Methodology to Define a Pharma 4.0™ Industry 3.0

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DiversifyRx

AUGUST 10, 2022

Watch out for communication when it is live. A great FDA-registered device called the V-Comb is a hot seller too. You can even package them as teacher gifts too. Kristin Tallent’s signature point of care testing course in the membership just in time to be ready for the start of the peak season towards the end of October.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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ISPE

NOVEMBER 2, 2022

Pfizer was able to build close to two years of supply of products for the vaccine; it had to quickly scale up for producing billions of doses in a very short period of time, so Pfizer looked to ramp up drug substance, drug product, and packaging in many sites around the world in record time. Celebrate success and milestones. Andres Angelani.

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European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. What is the main reason submission of the DVA qualification to FDA is significant for future clinical trials?

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The Checkup by Singlecare

JULY 10, 2024

You’ve probably eaten seaweed as part of your favorite sushi dish before or even snacked on a package of dried seaweed from the shelf of your local health food store. When you don’t get enough of this mineral, your thyroid-stimulating hormone (TSH) levels may rise too high, leading to hypothyroidism and other health problems.

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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ISPE

MARCH 29, 2023

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Direct feedback from the US FDA on this pilot is shared in the discussion.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry.” Draft Guidance for Industry.

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ISPE

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. As a result, some companies have challenged the paradigm by forgoing lyophilization entirely, opting to provide solution phase API to drug product facilities for filling and packaging.

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ISPE

MAY 9, 2023

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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The Checkup by Singlecare

MARCH 4, 2024

Food and Drug Administration (FDA) to help manage Alzheimer’s Disease. The manufacturer of dexamethasone products recommends withdrawal of anticholinergic agents at least 24 hours before initiation of steroid therapy in its packaging. It is also used off-label for other forms of dementia.

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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. It is considered a moderate change by the FDA (CBE30) and NMPA.

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ISPE

SEPTEMBER 11, 2023

m/s recommendation made its way into the US Food and Drug Administration (FDA)’s “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” 7 and into the EC GMP Annex 1 “Manufacture of Sterile Medicinal Products” in 2003. x, a free and open-source computational fluid dynamics (CFD) software package.

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ISPE

JANUARY 10, 2023

The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review. This article presents a proposed regulatory strategy to help alleviate supply risks for approved therapeutics.

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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. I like Boiron Arnica Montana 30C Meltaway Pellets , which you simply dissolve under your tongue. and magnesium citrate before bedtime.

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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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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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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Pharmaceutical Technology

JUNE 20, 2023

UK-based biotech F2G was dealt a blow as the US’ FDA issued a complete response letter rejecting its latest new drug application (NDA). F2G claimed in a June statement that the FDA requested additional data and analysis that extended beyond the current review period. Please check your email to download the Report.

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Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

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Pharmaceutical Technology

APRIL 21, 2023

On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription. The overdose US death rate that has seen a 250% increase from 1999 to 2019. Please check your email to download the Report.

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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. FDA expands approval labels. The FDA passed several positive supplementary approval decisions involving younger patients. Source: GlobalData Pharmaceutical Intelligence Center.

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Pharmaceutical Technology

FEBRUARY 23, 2023

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

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Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Many test methods have thus been developed.

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The FDA Law Blog

MARCH 30, 2025

Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States ( link , link ). By Charles D. Snow & Deborah L. Livornese & Ricardo Carvajal On March 18, 2025, the U.S.

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The Happy PharmD

MARCH 27, 2025

Unlike MSLs, who are often in the field, Medical Affairs pharmacists may work on developing educational programs, clinical trial strategy, or ensuring scientific accuracy in communications. Regulatory teams may face tight deadlines when a drug is nearing FDA approval. The best part? Many of these roles are remote.

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Pharma Marketing Network

APRIL 3, 2025

The Digital Transformation of Patient Marketing Technology has revolutionized how pharma communicates with patients. Additionally, integrating offline and online experiencessuch as QR codes on packaging leading to mobile resourcesenhances the continuity of care. How has patient marketing changed in recent years?

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European Pharmaceutical Review

APRIL 2, 2025

11-13 Recent reports from US Food and Drug Administration (FDA) authors concluded that AI can usefully be applied to some aspects of ICSR (individual Case Safety Reports) processing and evaluation, but the performance of current AI algorithms requires a human-in-the-loop to ensure good quality. FDA Discussion Paper And Request For Feedback.

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