Drug Discovery World

MARCH 21, 2023

UK researchers, from the Wellcome Sanger Institute and collaborators, have used human stem cells and neurons to investigate what features influence how well CRISPR activation works for different sets of genes. The post New research begins to write the rules on CRISPR activation appeared first on Drug Discovery World (DDW).

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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.

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Pharmaceutical Technology

MAY 9, 2023

According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the fentanyl seized by the Agency contained xylazine. It makes sense to have a xylazine strip so you can check to see if your dope contains xylazine,” he says.

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Pharmaceutical Technology

APRIL 24, 2023

While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with certain medicines.

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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.

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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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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.

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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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World of DTC Marketing

OCTOBER 4, 2021

SUMMARY: The Facebook whistleblower lawsuit can be summed up in one sentence: Facebook prioritizes engagement above all else because it leads to more profits even if that engagement containing inflammatory information. Mt recommendation was no and was based on the amount of health misinformation I found on the site.

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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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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.

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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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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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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.

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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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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.

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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 →

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The Pharma Data

DECEMBER 14, 2020

14, 2020 — It could be more than just added calories: New research gives insight into why sugary drinks are a leading cause of obesity. adults, and researchers now report that the drinks also hinder hormones that quell hunger and regulate appetite. MONDAY, Dec. Glucose is found in honey, grapes, figs and plums.

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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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FDA Law Blog

MAY 23, 2023

Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021). 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).

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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.

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Drug Discovery World

SEPTEMBER 28, 2023

Though the vaginal and endometrial bacterial profiles vary widely between ethnicities and even individuals, research suggests that select microbiome species are linked to specific disease states in all populations. Fertility is another key area of clinical trial activity within the realm of female microbiome-focused research.

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XTalks

SEPTEMBER 28, 2023

This is because the US has more lenient food ingredient regulations, potentially exposing consumers to carcinogens and harmful chemicals. Most research, however, suggests that the amount of titanium dioxide ingested from food is minimal, posing little to no risk to human health.

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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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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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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.

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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.

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Drug Discovery World

JANUARY 26, 2023

Cancer cells can shrink or super-size themselves to survive drug treatment or other challenges within their environment, researchers have discovered. Study leader Professor Chris Bakal, Professor of Cancer Morphodynamics at The Institute of Cancer Research, London, said: “We think our research has real diagnostic potential.

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Drug Discovery World

MARCH 26, 2024

We were there to present the latest findings from our research. MT: What’s next for STORM’s research? In addition to STC-15 and our METTL1, our pipeline contains a number of preclinical programs that are advancing rapidly for the treatment of viruses, neurodegeneration, cancer, and immuno-inflammatory conditions.

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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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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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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.

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The Pharma Data

AUGUST 18, 2020

Johnson & Johnson statement on the launch of new CARE (Corona Accelerated R&D in Europe) consortium, Europe’s largest, multi-partner scientific research initiative dedicated to discovering and developing urgently needed treatment options for COVID-19.

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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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CTTI (Clinical Trials Transformation Initiative)

JANUARY 10, 2024

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders.

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Pfizer

AUGUST 11, 2022

The information contained in this statement is as of August 11, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. . Disclosure Notice . Recent Announcements. 08.11.2022. Pfizer Statement on Zantac Litigation. 08.03.2022.

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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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