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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 Drafts Guidance for Consideration for Inclusion of Pregnant Women in Clinical Trials – Part 2

6/7/2018

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 FDA Released Draft Guidance for Expanded Abbreviated 510(k) Program – Part 2

6/3/18

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.