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FDA publishes Draft Guidance for Industry: Processes and Practices Applicable to BIMO Inspections

06/18/2024

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On June 5th 2024, the US Food and Drug Administration (FDA) released a draft guidance for industry on the processes and practices that apply during an FDA Bioresearch Monitoring (BIMO) inspection in compliance with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Major Deadline Passes in EU Medical Device Regulation

06/11/2024

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Medical Devices in the European Union (EU) are regulated by the Medical Device Regulation (MDR) (Regulation EU 2017/745) which supersedes the previous Medical Devices Directive (MDD)( 93/42/EEC). MDR was implemented on May 26th, 2021 with a three-year transition period. MDR requires that all manufacturers of medium to high-risk medical devices be certified by a notified body.

FDA & NIH Work to Clarify Clinical Research Terminology

06/04/2024

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On May 6th, 2024 the US Food and Drug Administration (FDA) and the National Institute of Health (NIH) released a Request for Information regarding their recently developed draft: Glossary of Terms and Definitions. Innovations in the design and conduct of clinical trials, such as incorporating real-world data to generate real-world evidence, has led novel terms being used to describe these innovations.

FDA Looks to Optimize the Processes and Policies of Advisory Committees

FDA Looks to Optimize the Processes and Policies of Advisory Committees

05/14/2024

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On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.

CDER Unveils Center for Clinical Trial Innovation (C3TI)

04/30/2024

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On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.