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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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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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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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

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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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

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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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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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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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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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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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

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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Common Sense for Drug Policy Blog

OCTOBER 29, 2024

The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4 In 2023, the FDA approved a 2.7 mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively).

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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

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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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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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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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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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

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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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

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

Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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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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Practical Cheminformatics

NOVEMBER 16, 2024

The Easy Way to Split a Dataset It seems that the authors of every package for ML with molecules end up implementing their own methods for dataset splitting. Some groups have even implemented packages for specifically splitting chemical datasets. Some groups have even implemented packages for specifically splitting chemical datasets.

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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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Agency IQ

AUGUST 4, 2023

BY KIRSTEN MESSMER, PHD, RAC AUG 2, 2023 12:18 AM CDT Background The U.K.’s This reliance procedure was implemented on January 1, 2021, for a planned two-year span, but last September, MHRA extended the effective period for the procedure to the end of 2023. on June 20, 2023 and will apply starting January 1, 2025. and the U.K.

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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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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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Alta Sciences

AUGUST 15, 2023

Cost-Effective Sterilization Method tchichekian Tue, 08/15/2023 - 18:39 HTML Regulatory agencies, including the FDA and EMA, prefer terminal sterilization over aseptic manufacturing, as it is less complex, less costly, and easily reproducible―providing a higher level of sterility assurance and patient safety. Speak with one of our experts.

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Alta Sciences

JULY 11, 2023

VIRTUAL TOUR: Discover our In-House R&D and Formulation Laboratories tchichekian Tue, 07/11/2023 - 17:49 HTML Enhance Your Outcomes With Our Analytical Services Altasciences’ in-house R&D and formulation laboratories offer an extensive array of analytical solutions to support sponsors’ drug development and manufacturing programs.

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Alta Sciences

JULY 5, 2023

Custom Dosage Form Solutions for All Study Phases tchichekian Thu, 07/06/2023 - 00:13 HTML Versatile Dosage Forms―From Formulation to Market For decades now, our U.S.-based based cGMP manufacturing and analytical testing facility has been moving molecules from benchtop to market.

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