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. Member states are to draft penalties for non-compliance by June 30, 2025. The proposed regulation is divided into 9 chapters.

Packaging 40

Packaging Regulations Laboratories Animal Testing 40

Perficient: Drug Development

OCTOBER 3, 2024

Support and Compliance: Upgrading ensures continued support from HCL and compliance with industry standards and regulations. Download and extract the Update Package that you want to install. Add Update Package Repository Go to File > Preferences on the Home page and then select Repositories. Click on Add Repository.

Packaging 52

Packaging Compliance Licensing Licensing 52

Perficient: Drug Development

SEPTEMBER 26, 2024

Support and Compliance: Upgrading ensures continued support from HCL and compliance with industry standards and regulations. Download and extract the Update Package that you want to install. Add Update Package Repository : On the Home page, go to File > Preferences and then select Repositories. Database Update: 1.updatedb

Packaging 52

Packaging Compliance Licensing Licensing 52

Perficient: Drug Development

JUNE 4, 2024

By leveraging self-hosted runners for deployment, organizations can optimize control, customization, performance, and cost-effectiveness while meeting compliance requirements and integrating seamlessly with existing infrastructure and tools. Here are few advantages of self-hosted runners as given below.

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Compliance Packaging Regulations 105

Alta Sciences

APRIL 6, 2024

Let us navigate and mitigate these challenges for you with a team of logistical experts to: • Streamline regulatory compliance through optimized documentation practices. • Prioritize secure, temperature-controlled shipments with reliable couriers. • Ensure your samples maintain their integrity with temperature monitoring, robust (..)

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Packaging Compliance 52

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. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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Packaging Compliance FDA Production 44

Perficient: Drug Development

JULY 29, 2024

Setting Up Encryption and Decryption We’ll use the javax.crypto package in Java, which provides the necessary classes for encryption and decryption. Compliance : Helps in complying with security standards and regulations that mandate encryption of sensitive data. Selenium WebDriver library added to your project. getEncoder().encodeToString(encryptedPassword);

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Packaging Compliance Regulations 52

FDA Law Blog: Biosimilars

MARCH 21, 2024

As the new law unfolds—and as state laws regarding ingredients and packaging, as well as laws regarding environmental claims continue to affect the cosmetics and personal care industries—the topics covered at the conference have never been more relevant. By John W.M. Truly, these are complex considerations.

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Production Compliance Regulations FDA 62

The Premier Consulting Blog

MAY 4, 2023

Food and Drug Administration (FDA) published in March of 2022 pertaining to ophthalmic drugs and devices, titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product.

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FDA Packaging Compliance Regulations 52

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

The Premier Consulting Blog

MAY 11, 2023

In March of 2022, the agency issued a guidance document titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. The FDA granted a 12-month period for the affected applicants and manufacturers to develop appropriate policies and procedures to ensure compliance with the new requirements. solution eyedrops).

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FDA Compliance Regulations Production 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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Regulations Packaging Compliance Production 40

Fierce BioTech

JANUARY 12, 2024

Key Learning Objectives: Gain insight into the strategic use of minitablets in drug lifecycle management Learn how minitablets can offer flexibility in dosing and improve patient compliance, particularly for pediatric patients Explore the convenience offered to patients through the packaging of minitablets in unit dose stick packs, optimizing accessibility (..)

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Drugs Packaging Compliance Drug Development 52

FDA Law Blog: Biosimilars

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

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FDA Packaging Production Drugs 52

Perficient: Drug Development

JULY 11, 2023

In this blog post, we will explore how OmniStudio empowers document generation across a range of industries, enhancing efficiency, accuracy, and compliance. To get the document generation capabilities, you need to install ‘OmniStudio’ and ‘Salesforce Industry packages in the same org. A sample functionality comes with the package.

Packaging 81

Packaging Compliance Production Marketing 81

Perficient: Drug Development

JUNE 24, 2024

CTA Action Button (Shopify landing page) Composable Commerce Principles: Modularity : The commerce platform is decomposed into individual packages or components, each responsible for specific functions such as product management, cart, payment processing, search etc.

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Compliance Packaging Marketing Production 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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FDA Regulations Packaging Compliance 57

PPD

OCTOBER 18, 2023

However, an effective CRO doesn’t just perform assays; it provides comprehensive project planning, and also compiles, analyzes and packages data into an actionable and appropriate format for each individual client. Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money.

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Laboratories Assay Development Small Molecule Drug Development 52

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.

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Compliance Regulations Packaging Production 40

Perficient: Drug Development

AUGUST 1, 2023

We tested component functionality, visual design, responsiveness, performance, usability, accessibility, and ADA, HIPAA, and SOC2 compliance. HTL Loader According to the README file, the “HTL Engine for JavaScript” is usually paired with the NPM package “ HTL Loader ” written by Thomas Jaggi and Tobias Bocanegra.

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Engineering Packaging Compliance Licensing 52

Agency IQ

NOVEMBER 10, 2023

The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDA approval before they may be used in cosmetics.

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Production FDA Compliance Packaging 40

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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Packaging Regulations Compliance Production 40

The Pharma Data

MAY 26, 2023

The 6,000-square-meter Shiga site opened in October 2021 to support customers both locally and globally, providing flexible clinical supply solutions, including primary packaging, Catalent’s FastChain ® demand-led supply, white glove handling and logistics. With sites in the U.S.,

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Clinical Supply Therapies Clinical Trials Packaging 52

Agency IQ

MAY 10, 2024

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. However, Maine (and some other states) have more broadly focused on banning all intentionally added PFAS in products after a certain date.

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Packaging Production Regulations Compliance 40

Agency IQ

AUGUST 4, 2023

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. These features should not be included on outer packaging or immediate packaging, if there is no outer packaging.

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Packaging Licensing Licensing Regulations 40

The Premier Consulting Blog

NOVEMBER 8, 2022

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., The drug product is packaged and shipped as a solid powder. therapeutic drug/monoclonal antibody) Drug/device (e.g.,

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Production Efficacy & Potency Packaging FDA 52

FDA Law Blog: Biosimilars

MARCH 3, 2024

This guidance will be critical because the Act leaves open a number of key questions that would be important to compliance and changes to the FAR are not required until a year after the guidance—and therefore after the effective date.

Small Molecule 101

Small Molecule Government FDA Approval Regulations 101

The Pharma Data

AUGUST 7, 2020

CluePoints provides clinical studies with risk management support package during Covid-19. Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: “The response to our complimentary risk assessment package has been fantastic. Download the e-book here. Source link.

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Clinical Trials Trials Packaging Therapies 52

Agency IQ

FEBRUARY 23, 2024

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. 2030 is a short timeframe for compliance in supply chains.

Packaging 40

Packaging Regulations Production Compliance 40

Agency IQ

SEPTEMBER 15, 2023

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. On July 1, 2021, DTSC designated carpets that contain PFAS as a Priority Product under agency regulations.

Regulations 40

Regulations Packaging Production Organic Chemistry 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

DrugBank

SEPTEMBER 12, 2024

It enhances transparency by documenting the meaning, source, and context of each data point, which is crucial for maintaining compliance and making informed decisions about data usage.

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Production Government Packaging Research 78

Drug Target Review

AUGUST 6, 2024

Regulatory support is another critical service provided by CDMOs, helping navigate the complex regulatory landscape for ADCs and ensuring compliance with global standards. Their assistance in preparing documentation and data for regulatory submissions is invaluable.

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Therapies Pharmaceutical Companies Disease Treatment 117

The Premier Consulting Blog

NOVEMBER 16, 2022

For example, they may develop a long-acting formulation that improves patient compliance or use a new route of administration that improves efficacy or increases ease of use. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible.

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FDA Packaging Production Compliance 52

PPD

SEPTEMBER 6, 2023

Through rebadging, sponsors can maintain continuity on key development programs while avoiding costly severance packages and payouts. A well-managed rebadging model represents an ideal pathway to full ARD compliance.

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Clinical Research Regulations Packaging Drug Development 59

Advarra

JUNE 6, 2022

This area needs to operate under full cGMP (manufacturing, quality control [QC], packaging, quality assurance [QA], and logistics). There may be cases when the existing process needs adjustments based on regulatory requirements, and/or compliance issues. managing projects, business, and compliance).

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Compliance Production Clinical Trials Packaging 52

Agency IQ

JUNE 7, 2024

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). In fact, regulators recently asked for an IVDR compliance deadline extension. IVDR designations continues to lag behind MDR designations, as noted above.

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Regulations Compliance Packaging Production 40