XTalks

MAY 19, 2022

The US Food and Drug Administration (FDA) posted the company’s recall announcement , which includes a complete list of products affected by the recall. . Rather, they are specific packages of the “Gummies” variety of these products. So why is metal contamination such a common reason for launching voluntary recalls?

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Drug Discovery World

APRIL 17, 2024

Join DDW for this exclusive free event, ‘ rAAV genome sequencing with Oxford Nanopore uncovers transgene integrity and packaging impurities ’. The post DDW event focusses on rAAVs and long-read nanopore sequencing appeared first on Drug Discovery World (DDW). The event will be supported by Oxford Nanopore Technologies.

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Drug Discovery World

MAY 8, 2024

Join DDW for this exclusive free event, ‘ rAAV genome sequencing with Oxford Nanopore uncovers transgene integrity and packaging impurities ’. appeared first on Drug Discovery World (DDW). The event will be supported by Oxford Nanopore Technologies. The event will take place on 13 May, 4PM BST.

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XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

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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 agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Today, the U.S. 29 and Sep. The FDA, an agency within the U.S.

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Drug Discovery World

APRIL 24, 2024

Join DDW for this exclusive free event, ‘ rAAV genome sequencing with Oxford Nanopore uncovers transgene integrity and packaging impurities ’. The post How rAAV genome sequencing uncovers transgene integrity appeared first on Drug Discovery World (DDW). The event will be supported by Oxford Nanopore Technologies.

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

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BioSpace

FEBRUARY 3, 2021

From packaging errors and contaminants to serious adverse effects, there are many reasons why products in the life sciences industry get recalled. Here’s a look at some of the latest drug and medical device recalls.

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Roots Analysis

FEBRUARY 28, 2022

Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. One of the stages that require quality assurance is packaging of the drug product, as compromised packaging could have serious consequences.

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Drug Discovery World

FEBRUARY 8, 2024

The event aimed to help the audience understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development. Questions were fielded from the audience, which included: What analysis will be performed to evaluate host or other DNA contamination?

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XTalks

APRIL 11, 2024

Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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Drug Discovery World

OCTOBER 3, 2023

The event aimed to help the audience understand the AAV workflow, from upstream methods for AAV production and validation to downstream analysis of the packaged product for enhanced therapeutic development. Questions were fielded from the audience, which included: What analysis will be performed to evaluate host or other DNA contamination?

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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. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use.

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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., The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. an Illinois-based processor of sprouts and soy products.

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XTalks

DECEMBER 20, 2021

While the voluntary recall has not been posted on the US Food and Drug Administration’s (FDA) website , reports indicate that the affected products were distributed in Connecticut, Maine, Maryland, New Jersey, New York, North Carolina, Pennsylvania and Virginia. Here’s everything you need to know about the Coca-Cola recall.

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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. plastic vacuum-packed packages containing ‘GROUND BEEF 85% LEAN/15% FAT’ with codes ‘EST#46841 L1 22 155’ or ‘EST#46841 L5 22 155’ on the side of the packaging.”.

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XTalks

FEBRUARY 8, 2024

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

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The Pharma Data

DECEMBER 30, 2020

Food and Drug Administration. Made in China, the recalled products are packaged in a white opaque or clear plastic bottle with either a blue, clear, or black cap and are labeled as IMC Wash-Free Hand Sanitizer, Wash-Free Hand Sanitizer, and Thrifty White Pharmacy Hand Sanitizer. WEDNESDAY, Dec. Shane Erickson Inc.

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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). MenuTrinfo’s certification scheme covers an exhaustive list of over 100 manufacturing points for a consumer packaged goods (CPG) brand to earn the seal for their products.

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XTalks

DECEMBER 1, 2021

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. Proper produce washing methods may not be pressing to most outside of professional kitchens, but the PD100 is making the case that it should be.

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FDA Law Blog

NOVEMBER 22, 2022

coli contamination. Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. Two days before Thanksgiving the following year, the CDC warned U.S. Concurrently, the U.S.

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The Pharma Data

NOVEMBER 4, 2020

Arizona’s law will allow adults aged 21 and older to possess, consume or transfer up to 1 ounce of cannabis and create a regulatory system for the drug’s cultivation and sale. ” Type 2 Diabetes Drug Metformin Recalled Due to Contamination with Carcinogen. Drug and Food Administration.

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XTalks

NOVEMBER 2, 2021

It also found detectible levels of phthalates in food handling gloves, which researchers said could be a source of contamination. Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging. What are Phthalates?

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The Pharma Data

DECEMBER 30, 2020

Food and Drug Administration said. Made in China, the recalled products are packaged in a white opaque or clear plastic bottle with either a blue, clear or black cap and are labeled as IMC Wash Free Hand Sanitizer, Wash Free Hand Sanitizer and Thrifty White Pharmacy Hand Sanitizer, CBS News reported. Shane Erickson Inc.

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Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

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XTalks

AUGUST 10, 2020

The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. These chemicals help prevent grease and oil from seeping through the packaging. Why PFAS in Food Packaging Is a Problem.

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Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

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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. Each room is developed to deliver a specific environment to unique ISO standards to avoid contamination. About the author.

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XTalks

MAY 30, 2023

XTALKS WEBINAR: Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems Live and On-Demand: Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn about on-body drug delivery systems and addressing their complex global regulatory requirements.

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Roots Analysis

SEPTEMBER 29, 2023

Closed System – To ensure that there is no chance of contamination or leakage of liquid nitrogen used for freezing and storage of goods, single-use bags can be fully sealed and vacuum packed. The system is ready to use, which reduces operator workload while simultaneously guaranteeing the quality of the final drug product.

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XTalks

APRIL 6, 2023

Raw flour is prone to contamination in the field by birds and animals as well as during harvest, transportation and processing. Flour doesn’t seem like a raw food, but most bagged flour that can be purchased from the grocery store is actually raw, meaning that it hasn’t been treated to kill the germs that cause food poisoning. History of E.

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Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination.

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Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

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Pharmaceutical Technology

FEBRUARY 3, 2023

As opposed to other therapies or drugs that basically help you manage a condition, gene therapy has the potential to cure a disease,” says Nicole Faust, PhD, General Manager, Cell Line Development, Cytiva. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. Biores Open Access. 2020 Oct 16;9(1):219-228.

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The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. brand packaged single head romaine lettuce with a pack date of Oct. recalled packaged single head romaine lettuce with a pack date of Oct. SILVER SPRING, Md. ,

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Drug Discovery World

FEBRUARY 8, 2023

In AAV therapeutics, empty capsids are those that are not packaged with the therapeutic DNA. Partially-filled capsids may also be present, and contain packaged process-related impurities or truncated genetic material. Robustness: to be able to tolerate matrix effects (type of buffer, residual contaminants, ionic strength, etc.)

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