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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Pharma in Brief

NOVEMBER 20, 2023

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.

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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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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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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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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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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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Camargo

OCTOBER 15, 2020

Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area. Natural history data becomes critical for product development when there is no concurrent control.

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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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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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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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XTalks

JANUARY 26, 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. Also in this episode, Sydney talks about the recent approval of house crickets in food products in the European Union (EU).

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pharmaphorum

AUGUST 12, 2022

The COVID-19 pandemic led to skyrocketing demand for some products while simultaneously constraining supplies due to logistical breakdowns and protectionist practices. The logic of outsourcing production to other countries, primarily China, suddenly looked dubious as Western countries struggled to import the drugs they needed.

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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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The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The FDA is working with the company to initiate a voluntary recall External Link Disclaimer of the affected products. Families rely on stores like Family Dollar for products such as food and medicine.

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XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast’s product portfolio includes Ostomy Care, Continence Care, Wound and Skin Care, Interventional Urology and Voice and Respiratory Care.

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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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XTalks

JANUARY 11, 2021

The word “sustainable” often gets tossed around in the food and beverage industry, with companies making certain claims about their products to market themselves as the better option. From sustainably-grown fruits and vegetables to sustainably-sourced coffee beans — not to mention sustainable packaging — what does it all mean?

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Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

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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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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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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

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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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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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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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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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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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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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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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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 Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. For companies selling products in California, it is not enough to simply follow the FTC Green Guides.

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Pharma in Brief

AUGUST 3, 2023

On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance ). Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act ( FDA ) and the Food and Drug Regulations ( FDR ).

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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XTalks

DECEMBER 19, 2023

From the mystery of missing ingredients to the introduction of unconventional products, these top ten food news stories on Xtalks.com showcase the food industry’s resilience, innovation and ever-changing landscape. It’s a stark reminder of the varying food safety and health regulations that exist worldwide.

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XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). While this act is intended to make it easier for consumers with food allergies to identify potential allergens in the products they purchase, many believe it falls short.

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XTalks

APRIL 11, 2024

As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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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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