Science Daily: Pharmacology News

FEBRUARY 8, 2024

Researchers have uncovered the first direct evidence that the West Antarctic Ice Sheet shrunk suddenly and dramatically at the end of the Last Ice Age, around eight thousand years ago.

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Agency IQ

JANUARY 4, 2024

In a long-anticipated draft report, the FDA has offered a vision for a series of potential improvements to the way it currently publishes guidance documents.

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BioPharma Drive: Drug Pricing

SEPTEMBER 1, 2023

The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.

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Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. What has the MDCG published recently?

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BioPharma Drive: Drug Pricing

SEPTEMBER 25, 2023

Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.

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Agency IQ

AUGUST 4, 2023

New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U. The Windsor Framework is a political agreement between the European Commission and the U.K. government to ensure that, in the wake of Brexit, Northern Ireland continues to receive critical supplies such as food and medicines.

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The Pharma Data

MARCH 5, 2021

Securities and Exchange Commission (SEC) and its “ Document d’Enregistrement Universel ” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers ( AMF ). These documents are available on the company’s website: [link]. Source link:[link].

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Science Daily: Pharmacology News

JANUARY 5, 2024

Researchers have identified microstructures in fossil cells that are 1.75 billion years old. These structures, called thylakoid membranes, are the oldest ever discovered. They push back the fossil record of thylakoids by 1.2

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Drug Patent Watch

MARCH 25, 2020

The post Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average appeared first on DrugPatentWatch - Make Better Decisions. This article was originally published by Hermann Mucke & Peter Mucke in Future Drug Discovery under a Attribution-NonCommercial-NoDerivatives 4.0

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Drug Discovery World

JULY 8, 2024

Novartis was found guilty of failing to update and recertify two documents hosted on a Novartis website to include up-to-date Entresto (sacubitril/valsartan) prescribing information. The companies were judged to have “brought discredit upon”, and “reduced confidence in”, the pharmaceutical industry.

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Agency IQ

JULY 26, 2024

BY AMANDA CONTI FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. The final document reflects the agency’s efforts to develop reference guides for its upload portals.

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Science Daily: Pharmacology News

JULY 10, 2024

A record-breaking swim by two lion brothers across a predator-infested African river has been documented in a new study. The researchers say the 1km swim is another example of iconic wildlife species having to make tough decisions to find homes and mates in a human-dominated world.

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Science Daily: Pharmacology News

MAY 29, 2024

According to a recent study, dogs trained to detect scent may be able to identify significantly lower concentrations of odour molecules than has previously been documented.

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Drugs.com

JUNE 28, 2024

FRIDAY, June 28, 2024 -- Scientists have documented the first case of Down syndrome in Neanderthals, a finding which also supports the notion that these cousins of modern man were capable of providing care and support to a vulnerable member of.

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Agency IQ

JULY 12, 2024

BY ALEXANDER GAFFNEY, MS, RAC The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond.

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Drug Discovery World

MARCH 4, 2024

Reproducibility suffers because assay protocols are not sufficiently documented, so that different team members run them with slight variation. AW : By providing comprehensive documentation of experimental details, protocols, and results, annotations preserve essential contextual information that might otherwise be forgotten or overlooked.

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Drugs.com

JUNE 6, 2024

a hefty document released Wednesday, the National Academies of Sciences, Engineering. THURSDAY, June 6, 2024 -- Long COVID continues to plague millions of Americans as the health costs of the pandemic linger four years later, a new report warns.In

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Quanticate

MARCH 5, 2024

The integrated summary of safety (ISS) and integrated summary of effectiveness (ISE) are critical documents required for regulatory submissions in the approval of new medicines/drugs or devices. What is an ISS and an ISE?

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Science Daily: Pharmacology News

MAY 28, 2024

Despite being widely documented, the underlying functional role is poorly understood. The toe tapping behavior of various amphibians has long attracted attention from researchers and pet owners. In a new paper, researchers demonstrate that Dyeing poison frogs modulate their taps based on specific stimuli.

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Research 87

Perficient: Drug Development

JUNE 25, 2024

To do this, utilize PDFBox, a Java library for managing PDF documents, in combination with Selenium, a potent web automation tool. Key Features: PDF Creation: Enables the creation of new PDF documents from scratch. Encryption and Decryption: Provides functionalities to encrypt and decrypt PDF files to ensure document security.

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Packaging 52

Science Daily: Pharmacology News

JULY 5, 2024

Two white dwarf stars collided, creating a temporary 'guest star,' now labeled supernova (SN) 1181, which was recorded in historical documents in Japan and elsewhere in Asia. A mysterious remnant from a rare type of supernova recorded in 1181 has been explained for the first time.

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Research 101

Science Daily: Pharmacology News

NOVEMBER 9, 2023

A new study documents how Greenland's peripheral glaciers have changed from 1890 to 2022. Using satellite images and a unique archive of historical aerial photos, researchers documented changes in the lengths of more than 1,000 of the country's glaciers over the past 130 years.

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Agency IQ

JUNE 28, 2024

BY AMANDA CONTI A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products. This administrative review is last procedural step before the FDA can publish the document.

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Cytel

MAY 16, 2024

This addition is crucial, as documentation is a serious and important aspect of our industry. Each of us must contribute to this documentation effort and stick to the principle “if it is not documented, it did not happen.”

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Clinical Trials Trials Compliance FDA 40

BioPharma Drive: Drug Pricing

JULY 10, 2024

With more Americans taking obesity medications, adjacent businesses are offering supportive services to offset side effects, collect data and document new health benefits.

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Agency IQ

JULY 22, 2024

The document mostly contains information that has already been released in previous editions, with a few interesting updates – and many updated release timelines. Fill out the form to read the full article.

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Drug Discovery World

OCTOBER 25, 2022

Multiple factors feed into the reproducibility crisis, but correctly recording and documenting experimental procedures and results is key to improving reproducibility. . There is a need for secure and reliable documentation of both the data and protocols (also sometimes referred to as metadata). It’s a huge and important issue.

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thought leadership

MAY 10, 2024

In January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.

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Production FDA Research Compliance 52

SCIENMAG: Medicine & Health

JANUARY 11, 2024

The effects of aging and external factors like UV exposure on skin are well documented. As people age or spend more time in the sun, their skin tends to become drier and more wrinkled, Credit: University of California San Diego The effects of aging and external factors like UV exposure on skin are well documented. […]

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Research 86

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Below are examples of key items auditors/inspectors look for during an audit.

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Agency IQ

MAY 28, 2024

BY LAURA DIANGELO, MPH A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Perficient: Drug Development

MARCH 5, 2024

Every developer should be instructed to reference and update this document as implementation evolves. Think about the following when using your SDR: Encourage your stakeholders to take an active role in governing and understanding the document to ensure that the right projects are being prioritized and the right data is being collected.

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Perficient: Drug Development

JULY 11, 2023

Every company needs documents for its processes, information, contracts, proposals, quotes, reports, non-disclosure agreements, service agreements, and for various other purposes. Document creation and management is a crucial part of their operations. What is Industries Document Generation? How to generate documents?

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Drug Discovery World

OCTOBER 9, 2023

The encouraging Phase I results in the Acclaim-1 trial document Reqorsa’s favourable safety profile thus far and show early efficacy in patients with NSCLC whose disease has progressed on Tagrisso,” said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex.

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Drugs.com

JANUARY 15, 2024

Food and Drug Administration conclude in newly released documents that marijuana has less potential for abuse than other drugs with the same restrictions and it should be reclassified as a less. MONDAY, Jan. 15, 2024 -- Scientists from the U.S.

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Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.

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