FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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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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Agency IQ

JULY 21, 2023

In 2019, the advocacy organization, Friends of Cancer Research (FOCR) organized a multi-stakeholder initiative comprised of industry, government, and academia to find out. In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology.

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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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Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. Read This paper explains how synthetic biology is regulated in Europe. Nucleic Acids Research. Nucleic Acids Research. ” Nucleic Acids Research. .

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Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. Read This paper explains how synthetic biology is regulated in Europe. Nucleic Acids Research. Nucleic Acids Research. ” Nucleic Acids Research. .

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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.

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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

By continuously listening to and incorporating user feedback, we make sure that firefly meets the evolving needs of researchers, helping you to work more efficiently and focus on what truly matters - delivering impactful results. 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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