Perficient: Drug Development

OCTOBER 14, 2024

Example: An electronics company classifies items into components, finished products, and packaging materials. Example: A pharmaceutical company classifies its items into active pharmaceutical ingredients (APIs), excipients, and packaging materials. Item classification helps ensure that procurement processes adhere to these standards.

Packaging 52

Packaging Compliance Production Pharmaceuticals 52

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. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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Regulations Packaging Production Organic Chemistry 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.

Packaging 52

Packaging Compliance Licensing Licensing 52

Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this 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.

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

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.

Packaging 52

Packaging Compliance Licensing Licensing 52

FDA Law Blog: Biosimilars

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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Regulations FDA Production Government 44

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.

Compliance 105

Compliance Packaging Regulations 105

Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this 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.

Regulations 40

Regulations Clinical Trials Production Trials 40

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this 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.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

Regulations 40

Regulations Production International Packaging 40

FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M. Truly, these are complex considerations.

Production 62

Production Compliance Regulations FDA 62

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.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

The Premier Consulting Blog

MAY 11, 2023

In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. In March of 2022, the agency issued a guidance document titled Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4.

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FDA Compliance Regulations Production 52

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.

FDA 52

FDA Packaging Compliance Regulations 52

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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FDA Regulations Packaging Compliance 57

Agency IQ

JUNE 21, 2024

Commission proposes guidelines to flesh out the newly finalized Variations Regulation This week, the newly finalized Variations Regulation was published in the Official Journal of the E.U. An updated guideline implementing the changes from the new regulation is now open for public consultation until August 23, 2024.

Regulations 40

Regulations Production Marketing Vaccine 40

FDA Law Blog: Biosimilars

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Most of the compliance dates have been passed. By Philip Won & Lisa M.

Packaging 44

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.

Packaging 52

Packaging Compliance Regulations 52

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. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

Regulations 40

Regulations Production Packaging International 40

Agency IQ

AUGUST 30, 2024

An introduction to EU chemicals guidance In the internet age, meeting regulatory obligations starts with knowing where to pinpoint the right resources in the vast ocean of information to guide you successfully through the often-labyrinthine processes of EU chemicals regulation.

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Compliance Regulations Packaging Production 40

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Regulations FDA Science Production 40

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.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

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 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. The provisions in Annex 2 of the Brexit legislation will also apply unless the new regulation changes those.

Packaging 40

Packaging Licensing Licensing Regulations 40

Agency IQ

AUGUST 23, 2024

ECHA issues guidelines for enforcing mixture classification based on bridging principles ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures.

Packaging 40

Packaging Regulations Compliance Production 40

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.” NOV 8, 2023 10:02 PM CST Regulatory background The Federal Food, Drug, and Cosmetics Act (FD&C Act) is administered by the Food and Drug Administration (FDA) and regulates cosmetics.

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Production FDA Compliance Packaging 40

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. If passed, the law would go into effect in January 2025.

Packaging 40

Packaging Regulations Production Compliance 40

FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

Small Molecule 101

Small Molecule Government FDA Approval Regulations 101

Agency IQ

FEBRUARY 23, 2024

Background: PFAS regulation in California PFAS have been the subject of significant regulations in California, beginning in the 2010s [for an in-depth review of PFAS regulation in California, see the AgencyIQ analysis here ]. In 2019, the state began to significantly ramp up its PFAS regulation and research.

Packaging 40

Packaging Regulations Production Compliance 40

Agency IQ

JULY 26, 2024

EU executive consults on proposed update to PIC chemical lists Regulation (EU) 649/2012 (PIC Regulation) is the main act on the export and import of hazardous chemicals between the European Union and third countries. Part 1 of the annex lists substances that carry the obligation to submit an export notification.

Regulations 40

Regulations International Packaging Compliance 40

Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

Regulations 40

Regulations Compliance Packaging Production 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.,

Production 52

Production Efficacy & Potency Packaging FDA 52

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. It also proposed several packaging changes to safeguard against misidentification. The Medical Gas Safety Act , introduced by Rep.

FDA 40

FDA Regulations Production Packaging 40

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

Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Most notably, the bill pushes the time for compliance with the 2021 statute from January 1, 2023, to January 1, 2025.

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Production Regulations Compliance Packaging 40

Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

Regulations 40

Regulations International Government Compliance 40

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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