Drugs.com

OCTOBER 25, 2023

25, 2023 – Federal regulators are investigating a salmonella outbreak linked to packaged, diced onions that has sickened at least 73 people across 22 states. WEDNESDAY, Oct. Fifteen of the illnesses were so bad that people required.

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Drugs.com

SEPTEMBER 20, 2023

21, 2023 -- Highly processed packaged foods and drinks may be quick, cheap and tasty, but new research suggests they’re also likely to up your risk for depression. THURSDAY, Sept. Among big consumers of ultra-processed foods, depression risk.

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Drugs.com

SEPTEMBER 22, 2023

22, 2023 -- Kraft Heinz said it is recalling over 83,000 packs of its Kraft Singles American processed cheese slices because of a packaging defect in the plastic that wraps the cheese slices. FRIDAY, Sept. A temporary issue developed on one of the.

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Packaging 290

Drug Discovery Today

APRIL 14, 2023

Through a series of exclusive interviews and a survey of industry insiders, Connect in Pharma names the top pharmaceutical and manufacturing-related trends of 2023

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KIF1A

OCTOBER 21, 2023

To transport each piece individually would be very inefficient, so molecules going to the same destination are often packaged into containers we call vesicles. Read the Article The post #ScienceSaturday: October 21, 2023 appeared first on KIF1A.

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KIF1A

APRIL 24, 2023

KIF1A.ORG has a lot to share this month including the 2023 KAND Family & Scientific Engagement Conference registration and hotel room links! Community Highlights 2023 KAND Family & Scientific Engagement Conference!! RDDS 2023 focuses on collaboration – the foundation of success in rare disease research.

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Eye on FDA

AUGUST 22, 2023

Second, a claim was made in the communication that OPDP said was not supported by the clinical studies section of the package insert. First, while presenting the indication in the posting, there was no risk information included in the communication. And third, the communication was not submitted under form FDA-2253 for review.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Devices can have both a UPC code and a UDI on their label and package.

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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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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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Drug Patent Watch

DECEMBER 12, 2024

This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more. 2023, August 9). 2023, July 19). 2023, February 23). Scalability and Flexibility The ability to scale production to meet clinical and commercial needs is vital.

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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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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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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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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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Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. The rule also banned regulated PFAS in juvenile products along with several other chemicals also as of January 1, 2023.

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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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Packaging 59

Agency IQ

FEBRUARY 15, 2024

European Commission unveils proposed ban on bisphenol A in food packaging The European Commission has proposed a total ban on bisphenol A and related substances for use in food contact materials. Analysis The Commission based its decision to ban BPA on EFSA’s April 2023 opinion , which established a new tolerable daily intake (TDI) of 0.2

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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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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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Packaging International Drugs Research 52

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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Pharmaceuticals Packaging Regulations Science 52

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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Broad Institute

DECEMBER 13, 2023

By Leah Eisenstadt December 13, 2023 Two teams of Broad researchers produced detailed maps of the mouse nervous system. The studies are part of a package of 10 papers in Nature that take distinct, yet complementary, approaches to mapping the mouse nervous system at the single-cell level. Nature 622 , 552–561 (2023).

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DNA Virus Research Engineering 140

Agency IQ

SEPTEMBER 29, 2023

chemical developments we’re expecting in October 2023 Welcome to AgencyIQ’s roundup of regulatory activities anticipated next month in the European Union chemicals sector. BY SCOTT STEPHENS, MPA | SEP 26, 2023 7:20 PM CDT Key regulatory actions on the horizon The renewal of approval of glyphosate. It will also enable E.U.

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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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The Premier Consulting Blog

APRIL 27, 2023

As of April 2023, the FDA is overseeing its eCTD v4.0 Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 Currently, eCTD v4.0 What are the implementation timelines?

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Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Large Language Models The emergence of GPT-4 and ChatGPT brought considerable attention to large language models (LLMs) in 2023. Papers published in 2023 showed how robust the method is. Other Stuff 4.

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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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Laboratories FDA Packaging Regulations 52

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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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. aligns the rules with other EU chemicals legislation – notably on biocidal products and classification, labeling and packaging.

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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. The EU executive will issue legislation in the first half of December at the latest renewing glyphosate’s approval, since its current approval expires on December 15.

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Perficient: Drug Development

FEBRUARY 29, 2024

Reverse Engineering the Existing SPA Editor The front-end portion of the SPA Editor is composed of five NPM packages. Of these five packages, three were specific to React or Angular. These are the three packages I would need to reverse engineer and replicate in Vue. of @adobe/aem-react-editable-components, version 1.1.8

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The ChEMBL-og

JUNE 13, 2023

Cardiff Schistosomiasis Dataset 2023 (src_id = 64): A library of 80 compounds were tested in vitro on different life cycle stages of the parasite Schistosoma mansoni. Data set retrieved from COCONUT team on 05/05/2023. Data set retrieved on 30/05/2023. The consortium also develops new transport assays for selected SLCs.

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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. No Toxics in Food Packaging Act of 2023 On October 26, 2023, Reps.

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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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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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