FDA Law Blog: Biosimilars

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

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PPD

OCTOBER 2, 2024

A recent white paper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.

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PPD

AUGUST 28, 2024

Regulators and payors also demand a higher volume of data collection for these studies. Access the white paper The post Patient-Centric Strategies for Successful Oncology Trials appeared first on PPD. There is a lot of competition in this area of drug development, and the regulatory landscape is increasingly dynamic.

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Agency IQ

JULY 8, 2024

BY WALKER LIVINGSTON, ESQ | JUL 3, 2024 4:40 PM CDT Background: FIFRA and antimicrobial pesticides Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA is responsible for the regulation of pesticides in the United States. To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com ).

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Agency IQ

MAY 10, 2024

The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.” Also this year, the FDA finalized its new rule on overhauling the medical device quality system regulations.

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The Pharma Data

SEPTEMBER 9, 2020

In order to capture and manage large amounts of data while conforming to regulations, laboratories need to transform and be digitalized by unifying data capture and providing an intuitive way of interacting with it. For further information on how we process and monitor your personal data click here.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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Agency IQ

NOVEMBER 10, 2023

However, FDA’s vision for OPQ to serve as a “single, agency-wide quality oversight program that applies a uniform set of standards to all regulated products, and which integrates quality review, evaluation, and inspection activities under one authority” was first publicized more than a decade earlier.

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Agency IQ

JULY 7, 2023

However, FDA’s vision for OPQ to serve as a “single, agency-wide quality oversight program that applies a uniform set of standards to all regulated products, and which integrates quality review, evaluation, and inspection activities under one authority” was first publicized more than a decade earlier.

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Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Agency IQ

JULY 21, 2023

In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint.

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Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. Read Asimov, a Boston-based company that uses software and a large library of genetic parts to design living cells, published a white paper that explains their technology in more detail. .” Nature Genetics. This review is a good place to start.

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Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. Read Asimov, a Boston-based company that uses software and a large library of genetic parts to design living cells, published a white paper that explains their technology in more detail. .” Nature Genetics. This review is a good place to start.

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Agency IQ

NOVEMBER 20, 2023

EPA issues white paper exploring the adoption of structured content and digital pesticide labels FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance The EPA’s Office of Pesticide Programs (OPP) is in the developmental stage of creating a structured pesticide and digital pesticide label.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S. Next, the U.S.

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Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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PPD

NOVEMBER 18, 2024

Effective monitoring of regulatory intelligence comes with big challenges The challenges inherent to PV RI encompass more than just regulatory complexity — though complexity is a major factor, given regulations are continually created, updated or revised, at all levels (regional, national and global), often all at the same time.

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sptlabtech

OCTOBER 31, 2024

Comprehensive audit trails for enhanced compliance and troubleshooting We’ve made significant improvements to firefly’s audit log system to better support both operational and compliance needs, including compliance with FDA 21 CFR Part 11 regulations. supports compliance with 21 CFR Part 11, check out our white paper.

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Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. at 77 (citation omitted).

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