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

JULY 26, 2024

These tiny particles, primarily from environmental contamination, can infiltrate the food supply. Plastics are ubiquitous in consumer and industrial products, ranging from packaging to automotive parts. Microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised.

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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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XTalks

NOVEMBER 23, 2023

Salmonella Outbreak from Poultry — The US A widespread Salmonella outbreak linked to contaminated poultry affected thousands across multiple states this year. This persistent strain of Salmonella , also known as REPJFX01, not only led to significant illnesses but also prompted a massive recall and stricter regulations on poultry processing.

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XTalks

SEPTEMBER 12, 2022

Food and beverage companies across the supply chain must always be prepared for new regulatory developments in 2022 as they seek to bring new ingredients and products to market. New regulations are often reflective of the supply chain, food safety and consumer trends. But one question remains: what can those products be called?

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XTalks

AUGUST 4, 2023

The Trader Joe’s recall situation has garnered significant attention in the past week, as the popular retail chain declared three different product recalls during the last week of July. The recalls affect cookies, broccoli-cheddar soup and falafel, raising concerns over possible contamination with foreign objects like insects or rocks.

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XTalks

APRIL 17, 2023

While food safety regulations and advances in technology have greatly reduced the incidence of such events, some of the worst food safety incidents continue to occur. The causes of these events varied, from contaminated food and water to zoonotic diseases and poor hygiene practices. coli O157:H7 bacteria.

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XTalks

MARCH 26, 2021

It does, however, regulate toxins in other consumer products including arsenic, lead and cadmium, and the agency previously declared them dangerous to human health, particularly to babies and children. Currently, the US Food and Drug Administration does not set limits on heavy metals in most baby foods.

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FDA Law Blog

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. Prior notice” informs FDA about the products it can expect to be offered for import into the country. By Sophia R. Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S.

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STAT News

JANUARY 10, 2023

Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Continue to STAT+ to read the full story…

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STAT News

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses. Continue to STAT+ to read the full story…

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XTalks

AUGUST 7, 2023

coli outbreak between 1992 and 1993 that claimed the lives of four children who had eaten contaminated burgers from the fast-food chain Jack in the Box. This heart-wrenching event prompted an increased focus on fast-food safety regulations. But the documentary argued that more regulatory work is still needed. It becomes a commodity.”

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XTalks

JULY 25, 2024

These systems are designed to monitor the journey of products from origin to consumption. Track and trace platforms in the food industry are digital systems that log detailed information about every stage of a product’s lifecycle. By using these platforms, companies can easily adhere to these regulations.

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The Pharma Data

NOVEMBER 18, 2020

The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).

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World of DTC Marketing

JULY 8, 2021

Some of the TV spots for drugs are horrible, and some products should even be on TV because of terrible fair balance. One consistent learning from ALL the research I have been involved in is that patients pick up when death is listed as a side effect and stay far away from the product.

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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. Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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XTalks

AUGUST 15, 2024

These tiny particles, primarily from environmental contamination, can infiltrate the food supply. In this episode of the Xtalks Food Podcast, Sydney talks about how microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised.

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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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pharmaphorum

MAY 5, 2022

Assuring end-patient safety through holistic contamination control. With advances in rapid microbiological methods, revised industry regulation, enhanced knowledge of innovative therapies, and novel testing methods, this industry is ever expanding. Sponsored by: Associates of Cape Cod, Bioscience International and Ecolab.

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The Pharma Data

NOVEMBER 6, 2020

Learn about new solutions for real-time and thorough monitoring of pharmaceutical water systems to ensure only the highest quality products are delivered to patients. Download Mettler Toledo’s white paper for: Insights on how to meet the demands of ever-stricter water testing regulations head on. Add bookmark.

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pharmaphorum

JULY 22, 2022

for an Improved, Efficient and Contaminant-Free Cleanroom. Stringent regulatory standards for product approvals, technological advancements in cleanrooms, initiatives taken by private organisations to create awareness regarding cleanroom and growth of the healthcare sector globally are among the few factors expected to drive the market.

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FDA Law Blog

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.

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XTalks

APRIL 18, 2024

In this episode of the Xtalks Food Podcast, Sydney talks about the discovery of elevated lead levels in cinnamon products, which has prompted a closer look at food safety practices and regulations. Cinnamon can become contaminated with lead through various pathways.

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Pharmaceutical Technology

OCTOBER 28, 2022

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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pharmaphorum

MARCH 19, 2021

Since the third quarter of last year DeepVerge’s scientists have been working to transform an AI-based water contamination detection system into a unit that tests for the presence of the coronavirus. A femtogram is 0.000000000000000001 kilograms. It has licensed in a patented breathalyser, the analysts noted.

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The Pharma Data

MARCH 29, 2022

Today’s action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice (CGMP) requirements) of the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food Regulation. Related Information.

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XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

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XTalks

JULY 26, 2021

Traditional meat production faces a wide array of safety concerns, from slaughterhouse sanitation to foodborne illnesses and much more. But just because plant-based meat production doesn’t involve slaughterhouses or mass production lines, doesn’t mean it is immune from safety concerns. FDA Regulation. Ultra-Processed.

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XTalks

AUGUST 12, 2020

Thomson International, a company based out of Bakersfield, California, has recalled red, yellow, white and sweet yellow onions shipped from May 1, 2020 until now due to potential Salmonella contamination. of Bakersfield, California, USA, or any products made with these onions. More about Salmonella.

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Camargo

AUGUST 5, 2021

The product was later approved to prevent organ rejection for heart ( 2006 ) and kidney ( 2009 ) transplants, the latter based on a single prospective clinical trial. A number of Camargo clients are stuck in situations similar to this, with such inspections being the only remaining hurdle before their products are approved. Stay tuned.

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XTalks

NOVEMBER 4, 2022

“The ability to rapidly test and detect these pathogens on food and processing equipment allows for immediate intervention and remediation that can reduce widespread contamination that results in loss of product, foodborne illness and subsequent devastating economic impact to the food producers associated with product recalls.”.

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XTalks

APRIL 19, 2023

Researchers at McMaster University in Canada have developed a rapid Salmonella test for detecting contamination in chicken and other foods, which could help to reduce the cost of food processing and improve food safety. In the US alone, the bacteria is estimated to cause around 1.35

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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XTalks

APRIL 12, 2022

the owner of Kinder Chocolate, Nutella and Tic Tacs, among other brands, is voluntarily recalling its Kinder Happy Moments Chocolate Assortment and Kinder Mix Chocolate Treats basket, due to possible Salmonella contamination. The problem, however, doesn’t lie in regulations, but in a lack of enforcement by member states. Ferrero U.S.A.,

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XTalks

MAY 18, 2023

Abigail Snyder, an assistant professor of food science, has been investigating the effectiveness of superheated steam in cleaning these environments and preventing contamination. Its dry nature makes it highly valuable in maintaining the quality of food products during processing. Instances of E.

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XTalks

NOVEMBER 22, 2022

Last week, the US Food and Drug Administration (FDA) issued its final rule on Requirements for Additional Traceability Records for Certain Foods , which includes food traceability protocols for a variety of food products susceptible to contamination. Related: Here’s How the FDA is Making it Easier to Trace Foods.

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