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Progress Update on the BsUFA III Regulatory ...

07/14/2025

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In January 2025, the US Food and Drug Administration (FDA) posted a progress update video about the third iteration of the Biosimilar User Fee Act (BsUFA III) regulatory science pilot program by sharing results from recent studies, outcomes of round table discussions, and upcoming milestones.

Progress Update on the BsUFA III Regulatory Science Pilot Program
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New Final Guidance Q&A on RRAs

07/08/2025

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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA.

New Final Guidance Q&A on RRAs
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BIMO Finds Objectionable Conditions During ...

06/23/2025

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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.

BIMO Finds Objectionable Conditions During Inspection
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FDA shares FAQs on IRBs

06/17/2025

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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.

FDA shares FAQs on IRBs
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Final Guidance Released on IRB Written ...

06/03/2025

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In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.”

Final Guidance Released on IRB Written Procedures

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ICH E6(R3) Annex 2 Draft Version is Now Available!

ICH E6(R3) Annex 2 Draft Version is Now Available!

12/23/2024

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On November 6th, 2024, the International Council of Harmonization (ICH) published the draft version of ICH E6(R3) Annex 2, a long awaited update to the good clinical practice (GCP) section of the ICH Harmonized Guidelines.

FDA Publishes Draft Guidance on Integrating RCTs into Routine Health Care

FDA Publishes Draft Guidance on Integrating RCTs into Routine Health Care

11/26/2024

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In September 2024, the US Food and Drug Administration (FDA) published a draft guidance for industry titled: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice in association with the FDA’s Real-World Evidence program. This guidance was released the day before their final guidance on Conducting Clinical Trials With Decentralized Elements, both guidance discuss the FDA’s current position on collecting health information from sources outside of the clinical research site in order to improve enrollment and protocol adherence to scheduled visits

FDA Releases Final Guidance on Decentralized Clinical Trials

FDA Releases Final Guidance on Decentralized Clinical Trials

11/18/2024

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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).