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

FEBRUARY 26, 2025

This article will explore the steps to import a.bacpac file into a local environment, focusing on practical and straightforward approaches. Run SqlPackage Put.bacpac file into the package folder.(ex: The file must be imported and restored locally to work with these databases in a local environment. Using the SqlPackage command-line.

Packaging 52

Packaging Production 52

Perficient: Drug Development

MAY 1, 2024

In this article, I will give a brief instruction on how to migrate data between Optimizely Content Cloud applications using the API. The purpose of this article is just to add another option, so we can consider whether it’s suitable for the task or not. Just installing the packages and it’s enough for most cases.

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SCIENMAG: Medicine & Health

JULY 21, 2023

Katy Börner’s team from the Luddy School of Informatics, Computing, and Engineering’s Cyberinfrastructure for Network Science Center has made significant contributions to constructing a Human Reference Atlas and has led or co-authored six research articles in a just-released HuBMAP package in Nature. Börner, Victor H.

Research 66

Research Packaging Engineering Science 66

Perficient: Drug Development

AUGUST 9, 2023

In this article, we’ll look at how to use Redis with Node.js You can download it from the official Redis website or use package managers like apt or brew. You can use the redis package available via npm: npm install redis Now, in your Node.js This is where Node.js and Redis come in. Setup: Ensure you have Node.js

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Agency IQ

AUGUST 23, 2024

BY Scott Stephens, MPA | Aug 19, 2024 9:33 PM CDT Background: classifying chemicals in the EU The EU uses the United Nations (UN) Globally Harmonized System (GHS) as the basis for classifying, labeling and packaging hazardous substances and mixtures. Currently, the CLP is aligned with the seventh revised edition of the GHS.

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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.

Packaging 59

Packaging 59

Agency IQ

MARCH 7, 2024

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. This marks the first update to the list, which first debuted in July 2023.

FDA 59

FDA Packaging Marketing 59

Agency IQ

AUGUST 4, 2023

The document specifically notes that it applies to “medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC,” the current European pharmaceutical legislation. Article 54(o) of the existing E.U. Definitions from the existing E.U.

Packaging 40

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Agency IQ

JUNE 7, 2024

Safeners and synergists are subject to the same approval conditions that active substances are under the PPPR’s Articles 4 and 5-21 , pursuant to Article 25(1)-(2). Under the PPPR, first-time approvals are expected to take between 2.5 PPPs using approved active substances must obtain separate authorizations at the national level.

Regulations 40

Regulations Animal Testing Production Marketing 40

Molecular Design

DECEMBER 31, 2023

My main criticism of BW2014 that is that the rhetoric is not supported by data and I’ve always seen the article as something of a propaganda piece. I was rather surprised that BW2014 had not cited a single article about how colloidal aggregation can foil drug discovery. Given that M2003 had been published over a decade previously.

Drugs 96

Drugs Packaging Cell Based Assays Small Molecule 96

KIF1A

OCTOBER 21, 2023

In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. To transport each piece individually would be very inefficient, so molecules going to the same destination are often packaged into containers we call vesicles.

Regulations 105

Regulations Doctors Disease Packaging 105

Agency IQ

AUGUST 30, 2024

The good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance. and other types of support (e.g.,

Compliance 40

Compliance Regulations Packaging Production 40

Agency IQ

NOVEMBER 20, 2023

readability of package leaflet, patient engagement). Summary of Product Characteristics and Package Leaflet), recommending that sponsors and regulators “explore the use of electronic media” to provide product information “in the future”. See also Article 11 of Directive 2001/83/EC.)

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Production Packaging Hospitals Regulations 40

Drug Patent Watch

DECEMBER 12, 2024

This article will delve into the key considerations and best practices for evaluating CDMO performance. This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more.

Drug Development 98

Drug Development Production Clinical Trials Pharmaceutical Companies 98

Agency IQ

AUGUST 30, 2024

he good news: ECHA offers a treasure trove of online guidance on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Classification, Labelling and Packaging (CLP), and other chemicals legislation, as well as other reference tools to help industry keep products in compliance.

Packaging 52

Packaging Compliance Regulations Production 52

Agency IQ

SEPTEMBER 29, 2023

On October 5, the European Parliament (EP) plenary is scheduled to debate and likely vote on its position on the proposed regulation for reforming Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). food packaging, kitchen and tableware and food processing equipment).

Regulations 40

Regulations Packaging Production International 40

Agency IQ

JUNE 17, 2024

This obligation to adhere to “self-regulation” (“Selbstkontrolle” in German) is laid out in Article 5 of ChemG and Article 26 of USG. see the explanatory document regarding Annex 3 in French) [ For more background, see AgencyIQ’s January 24 article.

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Regulations Production International Packaging 40

Agency IQ

MAY 3, 2024

It amends the limit value for the presence of PBDEs in mixtures or articles. food packaging, kitchen and tableware and food processing equipment). Under REACH, these address testing proposals for seven entries, including dibromomethane, diethyl succinate and triisobutyl phosphate.

Regulations 40

Regulations Packaging Production International 40

Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. active pharmaceutical ingredient, fill/finish, packaging/labeling). Read AgencyIQ’s analysis of the non-paper.] points of disruption).

Regulations 40

Regulations Production Packaging FDA 40

Agency IQ

SEPTEMBER 22, 2023

Article 69 of the BPR regulates the labeling of all biocides, including biocidal disinfectants. Subsections (f) and (g) of this same article mandate that all authorized uses, as well as the directions for those uses, are printed clearly and indelibly on labels. Group 1 for disinfectants contains five product-types.

Regulations 40

Regulations Production Packaging Marketing 40

Agency IQ

JULY 12, 2024

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

Regulations 40

Regulations Packaging Production Government 40

Agency IQ

SEPTEMBER 15, 2023

California’s HSC defines a “ cosmetic ” as “any article, or its components, intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to, the human body, or any part of the human body, for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

Regulations 40

Regulations Packaging Production Government 40

Agency IQ

OCTOBER 27, 2023

aligns the rules with other EU chemicals legislation – notably on biocidal products and classification, labeling and packaging. It amends the limit value for the presence of HBCDD as an unintentional trace contaminant in substances, mixtures and articles. food packaging, kitchen and tableware and food processing equipment).

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Regulations Production Packaging International 40

Agency IQ

JULY 26, 2024

This includes the submission of OMORs, public comments to administrative orders, formal meeting requests and packages, dispute resolution requests, administrative hearing requests, record request responses, as well as updates to drug listing information. What should be submitted to which portal?

FDA 40

FDA Production Regulations Packaging 40

Agency IQ

MARCH 1, 2024

ECHA consultations under BPR closing in March BPR: Potential candidates for substitution These consultations support the evaluating competent authority in assessing the availability of substitutes or alternatives to active substances found to be potential candidates for substitution in accordance with Article 10 of the BPR.

Regulations 40

Regulations Production Packaging Science 40

Agency IQ

SEPTEMBER 6, 2023

The meeting package should contain sufficient detail to meet the intended meeting objectives,” and should also “clearly indicate” the purpose of the meeting and allow FDA to “assess the potential utility of the meeting.” What should the meeting request package include?

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FDA Packaging Drugs Pharmaceuticals 40

PPD

MARCH 11, 2025

Addressing evidence gaps early enables health technology developers to optimize their development strategies and plan their health economic modelling sooner, to provide robust and comprehensive evidence packages that support their product’s value proposition.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

Agency IQ

DECEMBER 15, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

Packaging 40

Packaging Regulations Government Production 40

Agency IQ

FEBRUARY 2, 2024

Proposal for Delegated Regulation Initiative entry Draft act Persistent organic pollutants – hexabromocyclododecane (HBCDD) Adoption was planned for first quarter of 2022 This act amends the limit value for the presence of HBCDD as an unintentional trace contaminant in substances, mixtures and articles.

Regulations 40

Regulations Production Government Marketing 40

Agency IQ

DECEMBER 1, 2023

For more background on the glyphosate authorization, see AgencyIQ’s October 12 article.] This measure will reduce the maximum PFOS concentration allowed as unintentional trace contaminant in substances, mixtures and articles and will remove the last specific exemption allowed in the EU since it is no longer needed.

Regulations 40

Regulations Production International Marketing 40

Perficient: Drug Development

AUGUST 3, 2023

Step 4: Install the MySQL Package for Node.js with a MySQL database, you need to install the MySQL package in your Node.js Type the command given below in a command prompt or terminal: npm install mysql2 This command will install the MySQL package and its dependencies in our Node.js To connect Node.js Step 5: Write Node.js

Packaging 52

Packaging 52

Agency IQ

FEBRUARY 12, 2024

Second, the submitters provide a full meeting package with detailed information on the development history and context, available data, and questions. FDA and EMA will review the package and meet to discuss the package before having a meeting with both agencies and the submitter to provide direct insight.

FDA 40

FDA Packaging Production International 40

Agency IQ

JANUARY 4, 2024

The Commission may be close to delivering this proposal , given that the EU executive recently adopted a package of related draft legislation in support of the CSS’s one substance-one assessment (1S1A) ambition. Two of the package’s proposed acts address the reattribution of tasks among EU agencies associated with chemical safety assessments.

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Regulations Packaging Production Government 40

Agency IQ

JUNE 7, 2024

The earliest a Notified Body could be designated to the MDR and IVDR was November 2017, according to MDR Article 123 and IVDR Article 113. There are two codes that all 49 Notified Bodies received designation to – devices with a measuring function (MDS 1010) and devices that require packaging/labeling (MDT 2011).

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Regulations Compliance Packaging Production 40

Codon

MAY 8, 2024

The book is an ode to scientific progress, and the articles within tell stories about everything from the origins of synthetic biology to the discovery of an antimalarial drug in China and the invention of the micropipette. We’ll package orders by hand and ship them out next week. If you are based outside the U.S.

Packaging 52

Packaging Engineering Vaccine Drugs 52

Agency IQ

JUNE 28, 2024

Requirements for clinical investigations under the MDR are outlined in MDR Articles 62 – 80 and Annex XV. Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. Data outside the PMCF (section 9.4)

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