Drugs.com

SEPTEMBER 8, 2023

8, 2023 -- The maker of the “One Chip Challenge” has pulled the product from store shelves after a Massachusetts mom claimed the super spicy chip, packaged in a coffin-shaped container, contributed to the death of her 14-year-old. FRIDAY, Sept.

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Perficient: Drug Development

JUNE 16, 2023

Salesforce Connections 2023 promised new ways for businesses and individuals to better drive innovation, efficiency, and growth – it did not just meet these expectations but exceeded them! A managed package brings forward the Sprout interface that allows service agents to respond directly to social threads directly on the case layout.

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Perficient: Drug Development

JANUARY 18, 2024

Install third-party NPM Packages Installing third-party NPM Packages in Optimizely Configured Commerce Spire CMS is a new functionality included in Optimizely’s most recent release. Optimizely uses the Workspaces feature of NPM to link the blueprint packages and the Spire package.

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thought leadership

MARCH 26, 2024

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation 1 to revise many of the currently applicable Regulations.

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Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Perficient: Drug Development

SEPTEMBER 19, 2023

Most Sustainable Dreamforce Ever 74% of structures were recycled or reused 5,500 square feet of biodegradable signage 10M gallons of water conserved 100% compostable meal packaging Multiple Net Zero Cloud sessions New Net Zero Cloud capabilities, including simplified ESG reporting for companies amid changing regulations; Einstein for Net (..)

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Fierce BioTech

DECEMBER 12, 2023

Is your organization harnessing the full potential of preclinical metadata for analyses, internal decision making, and to support R&D packages? mahart Tue, 12/12/2023 - 13:17 Inconsistent preclinical data collection can lead to compounding costs in drug discovery. Learn how with this must-have guide. Download now.

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Agency IQ

MARCH 7, 2024

This marks the first update to the list, which first debuted in July 2023. The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more. Fill out the form to read the full article.

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Agency IQ

NOVEMBER 3, 2023

Jan Schakwosky has introduced the No Toxics in Food Packaging Act of 2023, which seeks to ban the use of ortho-phthalates, per- and polyfluoroalkyl substances, bisphenol compounds, styrene, and antimony trioxide as food contact substances. Fill out the form to read the full article.

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Agency IQ

JANUARY 19, 2024

EMA’s 2023 new medicines report suggests return to pre-pandemic volume This week, the EMA released its 2023 New Medicines Highlights report, providing insights into the number of opinions provided and the types of products reviewed. The number of opinions issued by the EMA in 2023 fell in comparison to the previous two years.

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FDA Law Blog: Biosimilars

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. By Karla L. the ability to associate the saleable return product with the transaction information/statement with the particular product). Guidance at 4.

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Cytel

JANUARY 3, 2024

1 The following December, a second version was released after public comments and, on December 16, 2014, the FDA stopped the clock, providing sponsors with a pivotal two-year window to adapt their methods of creating clinical dataset packages to comply with the FDA’s new required data standards for any study commencing after December 16, 2016.

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Drug Discovery World

JUNE 17, 2024

Our corporate finance team have seen some biotech companies with outstanding potential that is poorly packaged from an investment point of view – getting this right is worth its weight in gold (literally!). About the author Y ogan A Patel is a Partner at MHA and Head of MHA’s Pharma, Life Science and Med-Tech sector group.

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Cytel

DECEMBER 27, 2023

Perspectives covers a wide range of topics related to data submission and data integration, from ISS and ISE best practices to leveraging automation to the use of Define-XML 2.1, and much more. Here are some of the top topics covered this year:

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Cytel

MAY 24, 2023

As of March 2023, specifically for any study started on or after March 15, 2023, 1 the submission of SEND, SDTM, and ADaM packages to the FDA requires the use of Define-XML 2.1 while this is not yet the case for PMDA).

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Perficient: Drug Development

AUGUST 29, 2023

Sitecore recently announced they are moving away from MyGet and to NPMJS for its package provider. After November 2023 the MyGet public feeds will be unavailable and any SXA themes and publishing pipelines should be updated before that time. This change will affect three existing packages with the new prefix.

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The ChEMBL-og

APRIL 16, 2024

A significant effort has been made to correctly map the drug form of the EMA data by manually inspecting different EMA sources of information, such as the Product Information (Annex I: Summary of Product Characteristics and Annex III: Labelling and Package Leaflet) and/or Assessment Report, where available. University of Dundee: T.

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Agency IQ

JUNE 16, 2023

FDA set to unveil new rule on Laboratory Developed Tests this August Following challenges getting a diagnostics reform package through Congress, known as the VALID Act, the FDA has just announced that it plans to release a proposed rule in August 2023 that would change the way that the agency effectively regulates laboratory developed tests (LDTs).

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Broad Institute

JULY 19, 2023

Researchers reprogram gene therapy viral vectors to bind specific protein targets By Allessandra DiCorato July 19, 2023 Breadcrumb Home Researchers reprogram gene therapy viral vectors to bind specific protein targets A new screening method zeroes in on adeno-associated viruses that enter the brain through a defined mechanism. PLOS Biology.

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Agency IQ

NOVEMBER 20, 2023

BY KIRSTEN MESSMER, PHD, RAC | NOV 13, 2023 8:39 PM CST Background on electronic Product Information The European Commission (EC) has flagged the move to an electronic format for some product information as an area of improvement. readability of package leaflet, patient engagement). readability of package leaflet, patient engagement).

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Perficient: Drug Development

JANUARY 15, 2024

Implementation Steps Follow these steps to implement ELMAH in your ASP.NET application without using a conventional database: Install ELMAH NuGet Package Start by installing the ELMAH NuGet package in your ASP.NET application. This will automatically add the required dependencies and configuration settings.

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The Premier Consulting Blog

MAY 4, 2023

billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. Regulatory Focus.

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The Premier Consulting Blog

OCTOBER 1, 2023

PDUFA VII will be in effect from fiscal year 2023 through fiscal year 2027. It is the sixth reauthorization of PDUFA that provides the FDA with necessary resources and includes provisions to increase the efficiency of the drug development process. Check out our previous blog post to learn more about changes that came in PDUFA VII.

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FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

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Perficient: Drug Development

MAY 3, 2024

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Agency IQ

MAY 10, 2024

Geological Survey estimating in 2023 that at least 45% of the country’s tap water is contaminated with PFAS. Recently introduced legislation North Carolina: On May 1, 2024, North Carolina State Representative JOHN AUTRY introduced HB 973 , a bill to ban intentionally added PFAS in food packaging. with the U.S.

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PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care.

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DrugBank

NOVEMBER 7, 2023

EDMONTON, CANADA, November 1st, 2023— DrugBank today kicked off their role as a key distributor of the American Society for Health-System Pharmacists’s (ASHP) data. Discover ASHP Third-Party Packages in the Data Librar y ABOUT DRUGBANK DrugBank is the world’s first intelligent and comprehensive drug knowledge platform.

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Agency IQ

FEBRUARY 12, 2024

This edition reviews developments that occurred in late 2023 and early 2024. Insights from the Unified Agenda There are five PFAS-related rules on the Fall 2023 Unified Agenda released by the Office of Information and Regulatory Affairs (OIRA). EPA published its annual progress report on its PFAS roadmap in mid-December 2023.

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Agency IQ

SEPTEMBER 6, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 1, 2023 6:21 PM CDT Regulatory background A warning letter is a significant occurrence for a company, and in particular if it follows an inspection of a company’s facility. What should the meeting request package include?

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Agency IQ

JUNE 21, 2024

ECHA committees conclude evaluation of several PFAS uses subject to proposed restrictions ECHA’s committees for risk assessment (RAC) and socio-economic analysis (SEAC) met last week to continue work on developing opinions on the universal PFAS restriction proposal submitted in early 2023.

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Broad Institute

SEPTEMBER 13, 2023

Developing diagnostics and treatments By Rose Circeo September 13, 2023 Breadcrumb Home Developing diagnostics and treatments At the Broad Institute, researchers are revealing deep biological insights about the causes of disease, which are leading to new ways to monitor, diagnose, and treat patients with greater precision.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). This all sounds complicated, I know.

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Agency IQ

FEBRUARY 23, 2024

Geological Survey estimating in 2023 that at least 45% of the country’s tap water is contaminated with PFAS. In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. with the U.S.

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. This proposal is long overdue, as it was initially slated for the first quarter of 2023. [ The proposed regulation is divided into 9 chapters.

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Practical Cheminformatics

JANUARY 2, 2024

Here’s the first part of my review of some interesting machine learning (ML) papers I read in 2023. Review articles 2023 was a bit of a mixed bag for AI in drug discovery. In 2023, these methods underwent additional scrutiny, and it turned out that they weren’t quite as good as originally reported. Are the Comparisons Fair?

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