BioPharma Reporter

OCTOBER 6, 2021

A probe has identified 'human errorâ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6 million doses of the shot in August.

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STAT News

MARCH 14, 2023

The Environmental Protection Agency for the first time on Tuesday proposed enforceable regulations for “forever chemicals,” also called PFAS, in Americans’ drinking water. The six PFAS are the first new contaminants to be regulated under the Safe Drinking Water Act’s 1996 amendments.

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Scienmag

APRIL 12, 2021

UMD-led study warns cascading effects of salts require coordinated management and regulation to avoid contaminating natural resources Credit: Sujay Kaushal When winter storms threaten to make travel dangerous, people often turn to salt, spreading it liberally over highways, streets and sidewalks to melt snow and ice.

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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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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.

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World of DTC Marketing

FEBRUARY 28, 2021

SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties. Ethical leadership!

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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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World of DTC Marketing

AUGUST 26, 2021

The Supreme Court explicitly upheld vaccine mandates against deadly diseases in Jacobson, where it explained: “the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.”

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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

APRIL 1, 2021

In this week’s episode of the Xtalks Food Podcast, Sydney discusses the Baby Food Safety Act of 2021 which aims to help the FDA regulate heavy metal contamination in baby food. Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? Is there arsenic in your baby food? Read the full articles here: .

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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. This alert covers FDA-regulated products purchased from Family Dollar stores in those six states from Jan. Today, the U.S. Families rely on stores like Family Dollar for products such as food and medicine. “No

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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.

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Camargo

AUGUST 5, 2021

The FDA took advantage of this new approval to show how RWE can be used in lieu of prospective studies: “This approval reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data (RWD), when compared with a suitable control, can be considered adequate and well-controlled under FDA regulations.”.

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XTalks

SEPTEMBER 12, 2022

New regulations are often reflective of the supply chain, food safety and consumer trends. Here are some of the top food industry regulations food and beverage companies should watch out for in 2022. Regulating Heavy Metals in Baby Food. Cannabinoid Regulations.

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XTalks

MARCH 22, 2024

Pesticides continue to linger on our food, even on crops where their use has been banned, pointing to systemic issues in food safety regulations. The EWG also provides a “Clean Fifteen” list , highlighting produce with the least pesticide contamination. Reducing and Avoiding Pesticides It’s not all doom and gloom.

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NY Times

MAY 10, 2022

The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.

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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

MAY 16, 2024

Despite explicit cooking instructions on labels, the persistence of Salmonella -related illnesses underscores the necessity for strict regulations. Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. Subscribe to the Xtalks Food Podcast to never miss a new episode.

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XTalks

SEPTEMBER 17, 2020

Sprouts can carry a risk of foodborne illness if they are contaminated, and unlike other fresh produce, the warm, moist conditions required to grow sprouts are ideal for the rapid growth of bacteria, including Salmonella , Listeria , and E. No confirmed illnesses related to Fortune Food’s products have been reported to the FDA.

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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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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. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.

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XTalks

JULY 26, 2021

In another study evaluating the microbial load of a plant-based meats, the researchers concluded the products they studied were susceptible to post-processing contamination. FDA Regulation. The storage and handling of these products should mimic that of raw meats,” the authors wrote. Dietary and nutritional factors.

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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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XTalks

JULY 26, 2024

These tiny particles, primarily from environmental contamination, can infiltrate the food supply. Microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised. Macroplastics and microplastics are growing concerns within the food industry.

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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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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). Xtalks spoke to Betsy Craig, CEO and founder of MenuTrinfo, to find out how the company certifies products and where government regulations fall short. We go to the facility.

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XTalks

DECEMBER 20, 2021

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. coli , listeria or salmonella contamination in raw produce and meat, this is not the first beverage-related recall this year. While recalls tend to address E.

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XTalks

JUNE 7, 2022

They are caused by bacteria, viruses, parasites or chemical substances entering the body through contaminated food or water. An estimated 420,000 people in the world die every year after eating contaminated food, with children under five years old carrying 40 percent of the foodborne disease burden.

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XTalks

AUGUST 21, 2020

Breweries, for example, buy barley and malt from different parts of the world depending on the weather, to avoid the risk of mold contaminating their grain. Europe produces 70 percent of the world’s olive oils, with strong regulations governing its production and supply. But it’s not enough. Traceability.

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pharmaphorum

JULY 22, 2022

for an Improved, Efficient and Contaminant-Free Cleanroom. Key Reasons to attend: Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy. Increase your cleanroom availability & accessibility through streamlined approaches to contamination control. Advances in Pharma 4.0

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Pharmaceutical Technology

OCTOBER 28, 2022

Protein-based drugs are extremely expensive and so if you can create a biosimilar and potentially lower the cost, then this is an incentive for many companies to try to get into that marketplace, but also for regulators to encourage development.”. coli, where small amounts of contaminants could cause significant toxicity.

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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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XTalks

DECEMBER 1, 2021

Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases.

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XTalks

AUGUST 26, 2024

Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. In this episode of the Xtalks Food Podcast, Sydney talks about how lead contamination in food can arise and what the FDA is doing to monitor lead levels.

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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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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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Pharmaceutical Technology

FEBRUARY 3, 2023

Another immediate benefit is improved batch-to-batch consistency — something regulators are expected to tighten the rules on in coming years. In addition to high titers, ELEVECTA technology can offer a significantly simplified and more cost-effective supply chain without the need for expensive cGMP-grade plasmids and transfection reagents.

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