XTalks

FEBRUARY 4, 2021

Generation of strong research dataset cohorts must begin with high-quality clinical samples. Moreover, biobanks are no longer passive biorepositories for accrual of samples and serve a more utilitarian function in identifying and coordinating specific research cohorts for longitudinal and prospective studies.

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Research Biobanking Drugs Genome 98

World of DTC Marketing

MAY 24, 2022

In another study of apps for anxiety, scientists found that out of the 25 highest-rated apps for fear, exactly zero contained any content consistent with evidence-based treatments. While this sounds unfortunate, this may be related to the study methods in which researchers grouped interventions that may be completely different.

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Licensing Licensing Scientist Production 252

XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. However, products labeled “organic” may contain five percent non-certified organic materials. When is Food Considered Organic? The USDA has stringent rules for what is considered organic.

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Regulation Production Bacteria Packaging 52

WCG Clinical

DECEMBER 13, 2023

Dietary Supplements in Research Studies When used as investigational products in a study, dietary supplements may be subject to varying regulations and requirements. Next, let’s look at considerations for study design: Study objectives are crucial in defining the specific aim of the research and the intended use of the product.

Regulation 40

Regulation Research Production Compliance 40

pharmaphorum

JUNE 16, 2021

Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia. “Clinicians should be aware of these and articulate them to patients when determining the benefits and risks of mHealth apps,” they add.

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Containment Regulation Research Development 145

Camargo

SEPTEMBER 14, 2021

However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during development. The FDA’s Investigational New Drug (IND) application regulations cover all US clinical activities for drugs and biologics.

Clinical Trials 144

Clinical Trials Clinical Trials Medicine Production 144

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.

Packaging 98

Packaging Packaging Containment Production 98

XTalks

NOVEMBER 2, 2021

Researchers from George Washington University, the Southwest Research Institute, Boston University and Harvard University analyzed menu items from fast-food chains including Burger King, Chipotle, Domino’s, McDonald’s and Taco Bell.

Containment 96

Containment Hormones Contamination Packaging 96

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).

Development 161

Development Production Immune Response Licensing 161

pharmaphorum

MAY 5, 2022

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Enhance the interoperability of clinical research systems. A quick recap: Who are CDISC and what do they do?

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Research Trials 98

XTalks

OCTOBER 29, 2024

Protocols drive every clinical study, guiding research teams from early inception through planning and into the trial’s execution. Matthew Herod, MS Director, Enterprise Data Strategy PPD Clinical Research Business of Thermo Fisher Scientific With so many essential moving parts, it’s no surprise that it’s complex to manage protocols.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. China’s CanSino, Russia’s Gamaleya Research Institute and Janssen are also near the top of the list, along with US biotech Moderna.

Vaccination 104

Vaccination Vaccine Trials Protein 104

XTalks

JANUARY 17, 2023

The requirement for sesame to be listed on food labels was first signed into law in April 2021 thanks to the Food Allergy Safety, Treatment, Education and Research (FASTER) Act. Identifying which foods contain sesame is an important step in food safety and health care as an estimated 0.2 Related: Top 3 Allergy Friendly Food Brands.

Allergies 98

Allergies Packaging Packaging Containment 98

FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). This information is not included in the proposed codified language for the regulation.

Containment 52

Containment Production Protein Regulation 52

pharmaphorum

SEPTEMBER 15, 2022

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. full traceability throughout the research process. In this blog, we provide an overview of the CDISC standards used in clinical research. increased data quality. reduction of costs.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

AUGUST 15, 2023

In a nation where the majority of store-bought food contain incomprehensible ingredients and employ labeling tactics designed to confuse consumers, understanding the nature of our snacks and meals can often prove difficult. Same goes for instant mashed potatoes, which often contain BHA to keep it from spoiling on the shelf.

Hormones 98

Hormones Containment Production Packaging 98

XTalks

JULY 26, 2021

But several researchers and experts have brought to light some food safety concerns of plant-based meat, and why it must be treated differently than that of animal protein. Since most plant-based meats contain concentrated protein isolates, consumers may receive much higher doses of potential allergens. FDA Regulation.

Protein 98

Protein Contamination Allergies Bacteria 98

XTalks

APRIL 14, 2021

New research published in Science Advances has suggested that a natural cyan blue extracted from red cabbage could replace synthetic blue dyes in food. Food coloring is an essential part of the food and beverage industry; however, some research suggests that using synthetic dyes is not healthy for the consumer. 1, FD&C Blue No.

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Regulation Production Branding Research 94

Pharmaceutical Technology

APRIL 18, 2023

The document contains detailed information on the consent and preference management providers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Prioritisation and implementation of effective consent and preference management are important for the transparent and proactive management of data.

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Regulation Production Marketing Containment 130

Pharma in Brief

MAY 29, 2023

The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations ( CSP Regulations ) and to reflect changes to Health Canada’s administrative practices. Certificate of Supplementary Protection Regulations , SOR/2017-165

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Regulation Sales Clinical Trials Clinical Trials 59

XTalks

SEPTEMBER 13, 2021

According to a new study by the US Department of Agriculture’s (USDA) Agricultural Research Service (ARS) and University of California-Berkeley scientists, isochoric freezing “could cut energy use by as much as 6.5 Instead, only a small portion of the volume of water in the container is frozen. billion kg.”.

Containment 95

Containment Contamination Scientist Research 95

Pharmaceutical Technology

OCTOBER 26, 2022

According to GlobalData’s Nanopharmaceuticals Thematic Research report, the vast majority of marketed and pipeline nanopharmaceuticals are being used to treat a wide range of cancer indications, highlighting the ongoing unmet needs in this area. Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85

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Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

XTalks

JULY 27, 2023

Our response explains that we adequately considered relevant information and views contained in the administrative record when responding to the original citizen petition.” Recent research has shown that phthalates can adversely affect reproductive, developmental and endocrine health, with a specific emphasis on children.

Packaging 98

Packaging Packaging FDA Approval Production 98

BioTech 365

OCTOBER 22, 2020

This Announcement Contains Inside Information for the Purposes of Article 7 of Regulation (EU) No 596/2014 LONDON, Oct. 22, 2020 (GLOBE NEWSWIRE) — Abcam plc (AIM: ABC) (“Abcam”), a global leader in the supply of life science research tools, announces … Continue reading →

Life Science 40

Life Science Containment Regulation Research 40

pharmaphorum

MAY 24, 2021

Savana’s Dr Ignacio Medrano explains how machine learning and natural language processing technology is opening up huge amounts of previously-inaccessible real-world evidence (RWE) for pharma and regulators. One problem is that most RWE is contained in inflexible, siloed databases.

Drugs 83

Drugs Clinical Trials Clinical Trials Doctors 83

FDA Law Blog

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. 6, 2023 ( DOJ Press Release ). 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 60. Complaint ¶ 61.

Pharmacy 139

Pharmacy Containment Drugs Compliance 139

Pharmaceutical Technology

FEBRUARY 16, 2023

Stringent government regulations and the growing need for uncompromised quality have further encouraged demand. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.

Engineer 130

Engineer Manufacturing Containment Production 130

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

XTalks

MARCH 23, 2022

According to a new survey from consumer research platform Attest , 60 percent of US consumers are actively seeking food and beverage products to support their overall health. As part of its research, Attest showed participants six varieties of granola bars and asked them to identify which was the healthiest choice.

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Manufacturing Production Branding Packaging 120

XTalks

JANUARY 26, 2023

Identifying which foods contain sesame is an important step in food safety and health care as an estimated 0.2 Food containing house cricket products will require appropriate labels since some researchers believe that these insects could cause allergic reactions in consumers allergic to crustaceans, dust mites and mollusks.

Production 52

Production Containment Allergies Packaging 52

XTalks

JANUARY 12, 2022

According to the US Environmental Protection Agency (EPA), plastic containers and packaging make up a major portion of municipal solid waste, accounting for 82.2 Additionally, the recycling rate of generated packaging and containers was only 53.9 million tons of waste in 2018. percent in the same year.

Packaging 98

Packaging Packaging Scientist Bacteria 98

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

Production 52

Production Containment Biohazard Biohazard 52

Advarra

SEPTEMBER 29, 2022

Informed consent is one of the central protections the regulations provide to research subjects. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs). The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study.

Regulation 52

Regulation Research Genetics Compliance 52

Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Policies and Regulations Affecting Single IRB Review.

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Research 52

Trialfacts

AUGUST 26, 2024

This knowledge could lead to better regulation and more informed choices for consumers. Researchers from Yale University are studying the flavors of nicotine e-liquids and other tobacco products and their impact on appeal and addiction. Your Rights Who Can Participate? Who Can Participate? Study Location What’s Next?

Containment 52

Containment Research Production Regulation 52

XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release.

Drug Delivery 98

Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

XTalks

JUNE 21, 2024

The ban, endorsed by member states in April 2024, follows scientific research indicating harmful chemicals in smoke flavorings. The European Food Safety Authority (EFSA) found that smoky flavorings can contain harmful chemicals formed during the smoking process. Other companies, like I.T.S Other companies, like I.T.S

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Genotoxicity Regulation Production Manufacturing 52