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 64

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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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

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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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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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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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 Compliance 52

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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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

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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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 Regulations Production Compliance 40

Drug Discovery World

OCTOBER 25, 2022

Available features of an ELN ideally can be accessed through a user interface within a software platform that is nearly as easy to use as familiar office-based or online document sharing packages. . Regulatory compliance is crucial for organisations in many healthcare data-related industries. Data security .

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Laboratories FDA Compliance Science 130

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.

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Government Small Molecule FDA Approval Regulations 102

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 Packaging Efficacy & Potency FDA 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.

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Packaging Regulations Production Compliance 40

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

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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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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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 Compliance 59

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

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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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.

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Agency IQ

MAY 31, 2024

Even small changes in the Parliament’s composition could have an impact on ongoing legislative discussions, such as the revisions to the pharma reform package. The current European Parliament and Commission have confirmed their position on the pharma package, but the European Council is still working on its negotiation position.

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The Pharma Data

MAY 14, 2021

I’ve set up a discounted package system of 6 bottles of GlucoFlow for you, for only 49 dollars a bottle, for a total of 294 bucks which is being offered TODAYâ?¦for Just click the yellow button below after choosing the best package for you, and you’ll end up on our secure checkout page. for as long as supplies last.

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Packaging Production Compliance Doctors 52

Drug Discovery World

JULY 11, 2022

Managing these sensitive materials—including storage, transportation, and tracking—requires robust and adaptable systems to ensure safety, integrity, and regulatory compliance that are required for agency review. " Critical Considerations For Packaging And Delivery Of Gene Therapy Products." Molecular therapy.

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Agency IQ

JUNE 28, 2024

Most notably, the bill pushes the time for compliance with the 2021 statute from January 1, 2023, to January 1, 2025. ” This would give the agency leeway to require an even earlier compliance time for certain industries, however it must undergo a feasibility analysis before it can implement any prohibitions.

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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.

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Agency IQ

JULY 26, 2024

Affected stakeholders will then have until January 1, 2025, when the regulation begins to apply, to prepare for compliance with the requirements triggered by the listing of the new substances in annexes I and V of PIC Regulation. Chemical CAS RN (or EC No.)

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Vial

FEBRUARY 23, 2024

The HITECH Act invested $19 billion into health information technology, such as EMRs and digital patient portals, to serve as an economic stimulus package and incentivize their adoption by healthcare providers.

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Agency IQ

JULY 8, 2024

It also proposed several packaging changes to safeguard against misidentification. Medical gases were one of several topics during the deliberations that led up to the passage of the final legislative package, which was known as the Food and Drug Administration Safety and Innovation Act (or FDASIA).

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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. The declaration must state that the goods in question are in compliance with the rules applicable to them. eye damage, cat.

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Agency IQ

OCTOBER 27, 2023

policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

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Agency IQ

MARCH 7, 2024

Hojsik, a member of EP’s Renew Europe group, highlighted the revision of the regulation on the classification, labeling and packaging of chemicals (CLP) and its inclusion of new hazard classes as an important achievement over the past five years.

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Agency IQ

SEPTEMBER 22, 2023

Article 65 provides that member states must monitor biocidal products and treated articles to establish whether they are in compliance. Additionally, a label which has offloaded essential directions to technical sheets could be construed as non-compliant even though it may contain the statement, “Read attached instructions before use.”

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Regulations Production Packaging Compliance 40

Agency IQ

MAY 3, 2024

Trial Designs for Treatment Regimens with Multiple Phases Workshop Office of the Commissioner 05/09/2024 05/09/2024 Blood Products Advisory Committee May 9, 2024 Meeting Announcement Advisory Committee Meeting CBER 05/09/2024 05/09/2024 Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval Virtual CDER 05/09/2024 (..)

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Agency IQ

MARCH 7, 2024

BY WALKER LIVINGSTON, ESQ | MAR 5, 2024 6:33 PM CST Background: Food chemical safety at the FDA The FDA has primary authority over the chemicals used in food, including those used as food additives, colorants, in food packaging and more.

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