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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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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FDA Law Blog

MAY 23, 2023

the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement). The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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Containment Contamination Compliance Manufacturing 45

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

JULY 12, 2023

Enhanced processing, refrigeration, ice production and transportation methods have significantly broadened the commercialization and distribution of fish in diverse product forms over recent decades. mm resolution sensor to identify contaminants; however, it’s inadequate to detect pin bones and other sub-mm diameter bones.

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Contamination Containment Production Manufacturing 52

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

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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Roots Analysis

OCTOBER 24, 2023

HPAPIs, due to their selective mode of action, are effective in much smaller quantities than other therapeutic products. This has led to their widespread production and extensive use in the treatment of various indications including hormonal imbalances, oncological disorders and respiratory disorders.

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XTalks

SEPTEMBER 13, 2022

While the US Food and Drug Administration (FDA) would normally issue a recall, no recall was issued because the products are no longer available for purchase. The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert.

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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. g)(4) of the California Public Resources Code; or. g)(4) of the California Public Resources Code; or.

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FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0 Production Managers.

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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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Contamination Packaging Packaging Containment 98

XTalks

APRIL 14, 2023

Last month, Impossible Foods recalled its Chicken Nuggets Made from Plants and Wild Nuggies because of the possibility of small pieces of wood in the products. Consumers who may have purchased the products covered by the recall should dispose of them immediately and avoid consuming them.

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Production Containment Contamination Bacteria 52

XTalks

AUGUST 3, 2021

The National Council of Negro Women (NCNW) filed a lawsuit last week asking courts to make Johnson & Johnson create equally targeted “corrective marketing,” and/or fund outreach efforts warning Black women and their families about the risk of ovarian cancer associated with its product.

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Pharmaceutical Technology

OCTOBER 26, 2022

Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination. The updated NanoWitt offers five milling chambers, allowing the user to choose the size that best suits their production requirement.

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The Pharma Data

JANUARY 27, 2021

During the COVID-19 pandemic, there has been a large increase in hand sanitizers from Mexico that are labeled to contain ethanol (also known as ethyl alcohol) but have tested positive for methanol contamination, according to the agency. Food and Drug Administration says. consumers in mind.” ” More Information.

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The Pharma Data

DECEMBER 30, 2020

Regulators said that the first dose of the vaccine had 70% effectiveness in protecting against COVID-19 in the period between the first dose taking effect and a second shot. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy. Shane Erickson Inc.

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pharmaphorum

SEPTEMBER 23, 2020

The theme of the event is ‘Exploring Agile Contamination Control Strategy’, where the two-day conference will be co-chaired by James Drinkwater, Head of Aseptic Processing Technologies & GMP Compliance, F Ziel GmbH and Jim Polarine, Senior Technical Service Manager, STERIS Corporation. Workshop B 13.30 – 17.30 18 – 19 January 2021.

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Contamination Compliance Containment Regulation 52

XTalks

JANUARY 25, 2023

Abbott, the maker of Similac and other popular baby formula brands, was forced to recall several powdered infant formulas and stop production after the US Food and Drug Administration (FDA) found evidence of unsanitary conditions. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner?

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Bacteria Contamination Production Regulation 52

FDA Law Blog

NOVEMBER 30, 2022

Brevig, Senior Regulatory Device and Biologics Expert — Earlier this year, we posted on the still unsettled state of the law regarding whether “FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.”

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The Pharma Data

FEBRUARY 18, 2022

Centers for Disease Control and Prevention and state and local partners, the FDA is alerting consumers to avoid purchasing or using certain powdered infant formula products produced at this facility. This is an ongoing investigation, and the firm is working with the FDA to initiate a voluntary recall of the potentially affected product.

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XTalks

SEPTEMBER 13, 2021

While freezing is encouraged as a way to cut down on food waste and extend the lifecycle of a food product, it has several downsides that are often overlooked. The technique relies on storing foods in a firm, sealed container made of hard metal or plastic filled with a liquid like water, and placing it in a freezer.

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Drug Discovery World

MAY 11, 2023

However, the increased complexity and diversity involved in the development and manufacturing of gene therapies and vaccines can cause challenges when it comes to determining the quality of the final product, particularly around the detection of impurities. Impurities can integrate into the final product at various points during production.

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Production Gene Protein Vaccination 52

XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. The success of The Better Bagel reflects the growing market demand for low-carb and keto-friendly products.

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Packaging Packaging Containment Contamination 52

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. Behfar, senior scientist at VTT, in the news release.

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XTalks

FEBRUARY 20, 2023

The agency will use the proposed levels to determine whether to take enforcement action against baby food companies with products containing lead over that amount. The study also found that the US does not have strict regulations for commercially produced baby foods that are likely to contain toxic metals.

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Drug Discovery World

AUGUST 10, 2022

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks. Transfection efficiency with lentiviruses can range from 30 to 80% 11.

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XTalks

FEBRUARY 8, 2024

In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing. for a pack of three pens, each containing 1.5 While sales remain strong, they have been on the decline. This led to a 15 percent drop in sales compared to the previous year. mL of 300 units/mL.

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Pharmacy Checkers

NOVEMBER 21, 2019

As my greater advocacy initiatives have worked to implore the FDA to bring more balance, commonsense and fairness to regulating and providing consumer education about personal imports of prescription drugs, I’ve realized that I should practice the same in how I talk about the FDA. The medications that we obtain in the U.S., Far from it.

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The Pharma Data

MAY 13, 2021

Product Name: 101 Toxic Food Ingredients – New Conversion Breakthrough. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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The Pharma Data

APRIL 27, 2022

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice. Source link: [link].

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Cosmetics Production Containment Contamination 52

The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Hospital products, which grew 10% operationally to $2.3 Hospital products, which grew 10% operationally to $2.3 percentage points of operational growth.

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Pharmaceutical Technology

FEBRUARY 3, 2023

There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated.

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FDA Law Blog

DECEMBER 14, 2023

Conceding that they may disagree whether legalization of recreational cannabis or cannabis use is a “net positive,” the governors agreed that the cannabis industry is permanent, that states have implemented “strong regulations,” and supporting the state regulated cannabis marketplace “is essential for the safety of the American people.”

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FDA Law Blog

FEBRUARY 21, 2023

issued the release on January 26th stating that she had chaired an FDA “high-level internal working group to explore potential regulatory pathways for CBD products.” She also announced denial of three citizen petitions asking FDA to conduct rulemaking to allow CBD products marketed as dietary supplements.

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