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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XTalks

MARCH 22, 2024

According to the EWG, about 95 percent of nonorganic strawberries, certain leafy greens (including spinach, kale, collard and mustard greens), grapes, peaches and pears contain detectable levels of pesticides. The EWG also provides a “Clean Fifteen” list , highlighting produce with the least pesticide contamination.

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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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Contamination Containment Production Packaging 98

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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pharmaphorum

FEBRUARY 3, 2022

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. Uncover principles in best-practice and the benefits of a robust contamination control strategy. View the full agenda: [link].

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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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FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

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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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FDA Law Blog

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. CGMP deviations caused 56 recalls, and excipient manufacturers performed 51 recalls due to contamination.

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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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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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XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

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The Pharma Data

DECEMBER 30, 2020

30, 2020 — A hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, according to the U.S. Food and Drug Administration. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy. WEDNESDAY, Dec.

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XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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The Pharma Data

JANUARY 27, 2021

Food and Drug Administration says. 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. consumers in mind.” ” More Information.

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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. “The Coli illness.

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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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Sales Insulin FDA Approval Drugs 52

FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022.

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XTalks

AUGUST 3, 2021

Johnson and Johnson has faced thousands of lawsuits over its iconic baby powder, which people claim the company knew for decades contained asbestos. Talc and asbestos are often found together in nature, which is why mined talc can contain the carcinogen.

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pharmaphorum

AUGUST 24, 2020

She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Key sessions include: • Evaluating the ongoing Complications of Personnel Derived Contaminations.

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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). Mitigating Cross-Contamination with MenuTrinfo One of the most pertinent concerns for anyone with allergies is the potential for cross-contamination.

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Pharmaceutical Technology

OCTOBER 26, 2022

Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination. Billion in 2021 and is expected to reach USD 102.4 Billion in 2030.

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The Pharma Data

DECEMBER 30, 2020

Adding to the list of sketchy hand sanitizers and mouthwashes, a hand sanitizer has been recalled because it may contain methanol, a toxic chemical known as wood alcohol, CBS News reported Tuesday. Food and Drug Administration said. Shane Erickson Inc. Shane Erickson Inc.

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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. Since most plant-based meats contain concentrated protein isolates, consumers may receive much higher doses of potential allergens.

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Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. Aciclovir (acyclovir) is an antiviral drug, which stops the production (replication) of the virus at the site of infection. Generic Zovirax cream for cold sores As previously mentioned, Zovirax cream contains 5% of aciclovir. What is Zovirax cream?

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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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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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FDA Law Blog

NOVEMBER 30, 2022

According to the Realtor, these CIP qualification discrepancies “may lead to contamination” and “…over time [lead to] to adulterated [Gamunex] product and significant risk of patient harm.” 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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The Pharma Data

DECEMBER 28, 2020

(NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. Food and Drug Administration (FDA) for MydCombi , a unique fixed combination mydriatic (pupil dilation) agent.

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The Pharma Data

FEBRUARY 18, 2022

Food and Drug Administration announced it is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter. “As

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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

Roots Analysis

APRIL 19, 2022

Upstream processing primarily involves the use of single-use bioreactors, sensors, filters, media bags and containers, while in downstream processes, single-use technology is used for chromatography, centrifugation, filtration, sampling system and connectors. [1] 1] The history of bioprocessing technology is mentioned below. Web: [link].

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The Pharma Data

FEBRUARY 18, 2022

The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer.

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Roots Analysis

SEPTEMBER 20, 2023

Considering the vast potential of cellular therapies in the treatment of rare disorders and sufficient body of evidence validating the clinical benefits / therapeutic potential of this complex class of biologic drugs, cell therapy has garnered considerable attention of players engaged in the healthcare industry, in the past few years.

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Roots Analysis

SEPTEMBER 29, 2023

A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation. A user can easily handle the container and pre-installed tube combinations without the need for additional tools, equipment, or validation.

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Druggist

OCTOBER 4, 2020

Drug treatment can be used alongside lifestyle measures. Most of the drugs which are recommended in the symptomatic management of IBS can be purchased over the counter from pharmacies, supermarkets and online. IBS – drug therapy IBS medications are used for symptomatic management of the condition. Drugs to stop diarrhoea.

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