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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.
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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”.
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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.
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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.”
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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.
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:
In Part 1 of our blog series about Food and Drug Administration (FDA)’s draft guidance entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry, we discussed the introduction and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.
In Part 1 of our blog series about the Food and Drug Administration (FDA)’s draft guidance on inclusion of pregnant women in clinical trials entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry, we discussed the introduction and background behind the draft guidance. The FDA identified some risk-based ethical considerations for inclusion of pregnant women, including availability of other treatment options, the type and severity of the disease or condition being treated, and the stage of development of the drug (approved or investigational). The FDA recommends the sponsor consult an ethicist to evaluate the trial design, and the sponsor should have discussions with the FDA, including bioethics and maternal health experts, early in the development stage. In any case, the sponsor must follow the regulations for human subject protections.
The Food and Drug Administration (FDA) published a draft guidance on April 09, 2018 entitled Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials: Guidance for Industry. The public comment period is open until June 08, 2018, and instructions for submissions of comments can be found here.
In Part 1 of our blog, we discussed the introduction, background, and policy for the US Food and Drug Administration (FDA) draft guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. We will continue Part 2 of our blog with appropriate use of the Expanded Abbreviated 510(k) pathway, FDA’s identification of performance criteria, and data submission to the FDA.
