Blog — Clinical Pathways

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data integrity

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

09/10/2024

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In August 2024, the US Food and Drug Administration (FDA) released a final guidance for industry on drug-drug interactions (DDI) with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) titled: M12 Drug Interaction Studies. The guidance is intended to set the global standard and framework for conducting and reporting DDI studies in order to improve the efficacy of drugs as well as the safety and predictability of potential interactions between different drugs.

New Guidance for Industry on The Use of Real-World Evidence and Electronic Health Records in Regulatory Decision-Making

08/02/2024

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On July 25, 2024 the US Food and Drug Agency (FDA) published a final guidance for industry “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” This guidance is intended to help sponsors and other interested parties determine whether or not to use electronic health records (EHR) or medical claims data (information submitted to insurers to receive payments for treatments and other interventions) when making regulatory decisions on the effectiveness or safety of a drug.

Upcoming Public FDA Workshop on AI in Drug and Biological Product Development

Upcoming Public FDA Workshop on AI in Drug and Biological Product Development

07/23/2024

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The US Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI) announced an upcoming hybrid public workshop titled “Artificial Intelligence (AI) in Drug & Biological Product Development” on August 6th, 2024 at 10:00am-5:30pm EST. AI refers the area of computer science that creates intelligent machines intended to mirror human cognitive functions such as learning, recognizing patterns and relationships within datasets, adapting, and problem solving. AI is already being put to use in the field of clinical research.

FDA Releases New Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

07/05/2024

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In April 2024, the US Food and Drug Administration (FDA) released a draft guidance for industry titled: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. The draft guidance explains the difference between data quality and data integrity. While both are necessary to maintain in a clinical study in order to obtain reputable data, they each have important differences.

Comment Now! Ethical Considerations in Pediatric Studies Draft Guidance

09/27/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Ethical Considerations for Clinical Investigations of Medical Products Involving Children” in September 2022. The draft guidance clarifies the ethical principles for the conduct of pediatric clinical trials, including that children are a vulnerable population so additional safeguards are needed to ensure their safety. The safety of pediatric participants is covered under the FDA regulations 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations, and 45 CFR part 46, subpart D, Additional Protections for Children Involved as Subjects in Research.