# FDA RESUME - Unknown Company - Unknown Date

Source: https://www.keypedia.com/records/resume/unknown-company/e5622fc2-8732-45c3-ade7-beb95dac73e7

> FDA RESUME for Unknown Company on Unknown Date. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: RESUME
- Summary: Hugh Marcel McClure III is a seasoned Investigator and National Expert in Bioresearch Monitoring (BIMO) at the U.S. Food and Drug Administration (FDA), based in Columbus, Ohio. Since January 2011, McClure has been a pivotal figure in the Office of Regulatory Affairs, contributing 40 hours weekly to the advancement of inspectional and investigational techniques within the BIMO program. His expertise spans pre-market testing of pharmaceuticals, biologics, medical devices, and food additives, as well as inspections of non-clinical laboratories, clinical investigators, and biopharmaceutical labs.

McClure's role involves conducting high-profile and precedent-setting inspections, providing training to junior investigators, and developing educational courses for FDA personnel. He has significantly contributed to the creation and presentation of BIMO courses, ensuring comprehensive coverage of applicable regulations and current policies.

A key aspect of McClure's work is his involvement in various FDA working groups aimed at modernizing regulations and guidance documents. Notably, he has played a crucial role in the Good Laboratory Practice Working Group, tasked with updating the FDA's regulations for nonclinical laboratory studies (21 CFR Part 58). His contributions extend to drafting new regulations and addressing public comments during the rulemaking process.

Additionally, McClure is engaged in revising regulations related to bioavailability and bioequivalence (21 CFR 320) and contributing to the Generic Review Implementation Team under the Generic Drug User Fee Act. His efforts aim to standardize review processes and ensure the reliability of bioequivalence study data. McClure's extensive experience and regulatory insight continue to support the FDA's mission to uphold public health standards.

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## Related Officers

- [Hugh Marcel McClure III](https://www.keypedia.com/people/hugh-marcel-mcclure-iii/caa575d9-803a-43d5-a049-3edab8c2abf9)