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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

FDA FINAL Guidance for Electronic Health Record Data Released!

7/24/2018

The Food and Drug Administration (FDA) published a guidance document on July 18, 2018, entitled “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry,” which finalizes the draft guidance released in May 2016. The purpose of the guidance is to support industry in use of electronic data capture systems (EDC) and electronic health records (EHR) while protecting the confidentiality, integrity, and security of data. The guidance aligns with the 21st Century Cures Act, which prompted the FDA to publish guidance for use of “real-world evidence” in regulatory activities.

Remote Access to PHI

7/13/2018

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) released a guidance 21st Century Cures Act Guidance: Remote Access to PHI for Activities Preparatory to Research in December 2017 to clarify how protected health information (PHI) may be used via remote electronic access for research preparation activities.

Background:

  • The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule found in 45 CFR Part 160 and Subparts A and E of Part 164 describe how PHI may be used for research by a covered entity.

FDA Drafts Guidance for Consideration for Inclusion of Pregnant Women in Clinical Trials – Part 3

6/9/2018

In Part 1 of our blog series about Food and Drug Administration (FDA)’s draft guidance entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry, we discussed the introduction and background, and in Part 2 we discussed ethical considerations. Now in Part 3, we will discuss other considerations for enrolling pregnant women in clinical trials.