XTalks

AUGUST 12, 2024

Despite the elimination of many lead-based products in the US, certain goods, especially those imported, may still contain lead. Given that no safe level of lead exposure has been established, the FDA takes a proactive role in monitoring and regulating lead levels in food to protect public health.

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XTalks

OCTOBER 8, 2024

The 2024 Nobel Prize in Physiology or Medicine has been awarded to American scientists Victor Ambros and Gary Ruvkun for their groundbreaking discovery of microRNA (or miRNA) and its role in post-transcriptional gene regulation. A gene contains instructions within our DNA.

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Regulation Genetics Scientist RNA 52

Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. and around the world.

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Research Vaccination Vaccine Drugs 112

pharmaphorum

JANUARY 14, 2022

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

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Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

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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 Genomics 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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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.

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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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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.

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Clinical Trials Clinical Trials Medicine Production 144

Pharmaceutical Technology

MAY 25, 2023

The WHO report specifically notes that a multidisciplinary approach towards adherence is needed, requiring coordinated action from health professionals, researchers, health planners and policymakers. Some RPM apps, such as those from Huma, contain specific features that can help both patients and clinicians log and track medications.

Medicine 130

Medicine Doctors Doctor Regulation 130

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

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.

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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).

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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?

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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.

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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.

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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

XTalks

NOVEMBER 9, 2022

Since highly processed foods have become more prevalent in recent decades, researchers are still working to understand the full impact of these dietary shifts. Researchers found that the consumption of such foods may be the attributable cause of death in a significant percentage of deaths in the Brazilian population. .

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Containment Research Packaging Packaging 97

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.

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Protein Contamination Allergies Bacteria 98

pharmaphorum

JANUARY 27, 2021

In medical research, trust has traditionally been hard-fought for. People tend to remember when things go wrong, and this casts doubt over procedures and leads to questions about whether we can really trust industry, scientists, and researchers. However, what is usually left out is how those cases changed the way research is conducted.

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Research Clinical Trials Clinical Trials Vaccination 52

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

WCG Clinical

NOVEMBER 20, 2023

Why Was My Research Submission/Protocol Deferred? Research submission/protocols are deferred when the Board is unable to determine that the regulatory criteria for approval are met ( 21 CFR§56.111 and 45 CFR§46.111 ). If FDA determines that the research does not need an IND, FDA will issue a statement to that effect.

Research 52

Research Clinical Trials Clinical Trials Production 52

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 Drugs 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.”.

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Containment Contamination Scientist Research 95

XTalks

MAY 4, 2021

Researchers at the University of California San Francisco (UCSF) and the Whitehead Institute have developed a novel CRISPR-based tool called “CRISPRoff” that can switch off genes in human cells through epigenetic editing without altering the genetic sequence itself. The research was published earlier this month in the journal Cell.

DNA 98

DNA Gene Gene Silencing Genomics 98

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

Rethinking Clinical Trials

SEPTEMBER 13, 2023

DEVICE, part of the Pragmatic Critical Care Research Group, was a multicenter, parallel-group, unblinded pragmatic, randomized trial compared the use of a video laryngoscope with the use of a direct laryngoscope for tracheal intubation of critically ill adults at 17 EDs and ICUs across U.S. If most intubations in the U.S.

Trials 112

Trials Clinical Trials Clinical Trials Medicine 112

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.

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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

Pharmaceutical Technology

DECEMBER 9, 2022

M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. Pharmaceutical Technology Excellence Rankings – The Verdict. Quality control release testing.

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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.

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Pharmacy Containment Drugs Compliance 139

pharmaphorum

JANUARY 27, 2021

Information from the ‘cradle to grave’ care it provides has tremendous potential for driving more research within the UK, notably in oncology, with patients, regulators, payers, researchers, clinicians and the NHS itself all likely to benefit. Generating RWE to support oncology research.

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Clinical Trials Clinical Trials Research Trials 143