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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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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XTalks

AUGUST 12, 2024

Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. FDA’s Regulatory Framework on Lead in Food Lead contamination in food can arise from various environmental sources, including past usage of lead in paint, gasoline and plumbing materials.

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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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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 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

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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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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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

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 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

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

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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Pharmaceutical Technology

FEBRUARY 3, 2023

When you consider the existing challenges limiting the upstream production of viral vectors, this figure becomes even more alarming. We saw a huge potential for these stable cell lines; it’s really the most logical and efficient way to scale up AAV production. So, we set out to solve some of the problems,” she explains.

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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

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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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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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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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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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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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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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

AUGUST 21, 2020

The device will be able to detect if a product is organic or not and whether it is safe. They monitor potential triggers for food scams, which include harvest size, climate, political situations, food markets and the value of products. Many other countries, including the US, have their own controls and regulations for olive oil.

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XTalks

NOVEMBER 2, 2020

The requirements come from two specific FSMA regulations: the Preventive Controls for Human Food (PC Human Food ) and Produce Safety. And under three FSMA regulations, suppliers may also use third-party audits to verify their activities. Related: Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

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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

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

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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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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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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pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. Different ISO standards are required depending on the processes and products developed within the environment. Meeting strict standards. Enter cleanrooms-on-demand….

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XTalks

AUGUST 31, 2020

The study, “ Seeding of outbreaks of COVID-19 by contaminated fresh and frozen food ,” was published in the journal BioRxiv which circulates preliminary findings that have not been scrutinized by peer review. Related: Garden Gourmet’s Plant-Based Tuna Exploits Market ‘White Space’. “An

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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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Roots Analysis

JANUARY 27, 2025

In order to manufacture GMP regulated cell therapies, it is necessary to assess each manufacturing step at regular intervals. The development of cell therapy products requires a robust population of cells that can be subjected to genetic alterations, without being damaged in this process.

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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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XTalks

JUNE 7, 2022

The day emphasizes the importance of making food safety a priority for all to stay healthier and be more productive, which will in turn help reduce the pressure on health care systems. They are caused by bacteria, viruses, parasites or chemical substances entering the body through contaminated food or water.

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