Pharma Mirror

FEBRUARY 6, 2024

It has transformed from a “nice-to-have” into a “must-have” part of the evidence package, helping to contextualize clinical research and improve treatment understanding. In addition to utilizing RWE in clinical research, there is a growing trend toward implementing RWE early in the product development lifecycle.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.

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XTalks

OCTOBER 7, 2022

As awareness grows around the world about the problem of food waste, one culprit is being scrutinized: best before dates on food packaging. Confusion around date codes on food packaging is often cited as a contributor to food waste across the US and globally. So, will this trend emerge in the US?

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Packaging Packaging Manufacturing Production 97

Pharma Packaging Solutions

NOVEMBER 4, 2024

In the complex world of pharmaceutical packaging, selecting the right blister packaging supplier is a critical decision that can significantly impact product presentation, protection, and compliance. Material Selection Central to the blister packaging process is the selection of appropriate materials.

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XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.

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Drug Patent Watch

FEBRUARY 19, 2025

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. These dedicated individuals play a critical role in ensuring that generic drugs meet the same high standards as their brand-name counterparts.

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Generic Drugs Drugs Contamination Manufacturing 92

Camargo

AUGUST 11, 2021

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. As of January 1, 2021 , EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020.

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Pharma Packaging Solutions

JULY 17, 2023

As biopharma products become more common, so must biopharma packaging. Due to the sensitive nature of many biological products, there are strict federal regulations in place to ensure safe packaging and distribution. General Regulations (From Section 112.1) General Regulations (From Section 112.1)

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Packaging Packaging Containment Regulation 52

pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well.

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XTalks

SEPTEMBER 24, 2020

Related: FDA Issues First Injunction of its Product Safety Rule. In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects. Another part of the problem, according to the petition, is the Generally Recognized As Safe (GRAS) law.

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Regulation Hormones Containment Packaging 94

Outsourcing Pharma

NOVEMBER 10, 2021

According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.

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Packaging Packaging Pharma Packaging Manufacturing 69

Pharma Packaging Solutions

AUGUST 2, 2022

If you have ever taken any kind of medication, be it prescription or over the counter (and you almost certainly have), then you’re probably familiar with blister packaging. Blister packaging is extremely common in the pharmaceutical industry, thanks to its many benefits. Another benefit of blister packaging is convenience.

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Packaging Packaging Pharma Packaging Regulation 52

pharmaphorum

JUNE 10, 2021

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. Pharmaceutical Manufacturing & Packaging Congress provides the networking platform for the decision-makers from the pharmaceutical industry. Request business program via the link. .

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Packaging Packaging Manufacturing Pharma Packaging 52

Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. The meeting has several goals: Discuss issues critical to early product development.

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Gene Therapy Gene Packaging Packaging 155

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?

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Regulation Marketing Sales Branding 97

Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Iomab-B met the durable complete remission endpoint.

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Manufacturing Drugs Packaging Packaging 147

STAT News

OCTOBER 19, 2022

After years of deliberation, the FDA recently announced a new set of rules it proposes to regulate claims on food packaging that a product is “healthy.” ” The most basic rule: the product must actually contain food, not just ingredients.

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Packaging Packaging Containment Production 98

Camargo

NOVEMBER 15, 2021

It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements. In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”.

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Camargo

JANUARY 12, 2022

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. Receipt of Background Package. Response Time. calendar days).

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Production Gene Therapy Packaging Packaging 169

XTalks

JUNE 20, 2024

This rule would mandate front-of-package nutrition labeling, which would display key nutrient information on the front of the packaging, in addition to the existing nutrition label on the back. Also in this episode, Sydney talks about The US Food and Drug Administration’s (FDA) new requirement for prepackaged foods in the US.

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Packaging Packaging Protein Manufacturing 59

XTalks

APRIL 24, 2023

Dutch food and biotechnology company Corbion recently developed a new system to help bakers determine how long their products can stay mold-free naturally. The natural mold inhibitor is just the latest in Corbion’s wide range of offerings, which include food innovations, specialty ingredients and packaging products.

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Packaging Packaging Production Development 98

FDA Law Blog

JULY 22, 2024

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

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Cosmetics Compliance Production Regulation 59

Pharmaceutical Technology

MARCH 10, 2023

Freeze drying is a crucial technique to prolong the shelf life of pharmaceutical products. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state. The process eliminates the disadvantages of conventional drying methods or freezing.

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Manufacturing Production Containment Antibody 147

Outsourcing Pharma

NOVEMBER 10, 2021

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

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Packaging Packaging Manufacturing Production 52

FDA Law Blog

MARCH 2, 2022

By Riëtte van Laack — On February 18, 2022, the US Consumer Product Safety Commission’s (CPSC) Office of Compliance and Field Operations issued a guidance for household substances not intended for household use under the Poison Prevention Packaging Act (PPPA). No, that is not a typo.

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Packaging Packaging Production Sales 52

Pharmaceutical Technology

AUGUST 30, 2022

SUS provides full, free and universal access to healthcare for the country's entire population (215 million), which spends around 10% of its gross domestic product (GDP) on healthcare. Brazilian pharma production sites are involved in Covid-19 vaccine and therapy manufacture.

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Manufacturing Marketing Pharma Companies Vaccination 195

XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. According to the recall announcement that was posted by the US Food and Drug Administration (FDA), Sagent says the issue affects reserve sample vials that could lead to a non-sterile product.

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Drugs Packaging Packaging Containment 105

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Regulators are well-disposed to these boosters. 1 sub-lineage on 19 July. Moderna ready to compete with Pfizer for new variant business.

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Manufacturing Vaccination Vaccine Packaging 130

Pharmaceutical Technology

NOVEMBER 30, 2022

Contract manufacturing organizations (CMOs) are critical to ensuring the adequate and timely production of drugs and are involved in each step of the way. While the Lonza Group and Samsung Biologics are manufacturing the biological API, the latter is also in charge of the parenteral manufacture and packaging. NICE decisions.

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Roots Analysis

AUGUST 26, 2024

In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.

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Packaging Packaging Production Manufacturing 40

Pharmaceutical Technology

APRIL 5, 2023

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. The analysis found that PRIME improved evaluation times particularly for SMEs and advanced therapy medicinal products (ATMPs).

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Development Drugs Medicine Production 130

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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Cosmetics Production Compliance Regulation 64

Pharmaceutical Technology

APRIL 14, 2023

The regulator has issued a complete response letter. No concerns related to the clinical data package, safety or the medicine label. Mirikizumab also obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

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Manufacturing Drugs Hormones Packaging 130

XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Beginning this year, all food and dietary supplement manufacturers must clearly list sesame as an ingredient on product labels.

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Allergies Packaging Packaging Containment 98

XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. This update comes after a number of allegations claiming farmers have tried to sell non-organic or conventional food products with the lucrative white and green USDA “organic” label.

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Regulation Production Bacteria Packaging 52

XTalks

MAY 16, 2024

Also in this episode, Sydney talks about a new rule implemented by the US Department of Agriculture (USDA) that mandates lower Salmonella levels in frozen breaded and stuffed chicken products. Starting in 2025, poultry producers will be required to decrease Salmonella to very low levels in targeted chicken products.

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Regulation Contamination Packaging Packaging 52

XTalks

JULY 27, 2022

Pink Sauce, a product created and marketed by a woman who goes by Chef Pii on TikTok, has gone viral for all the wrong reasons. Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. I don’t sell medical products.”

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FDA Approval Packaging Packaging Production 98