WASHINGTON, D.C. — On Wednesday, the Food and Drug Administration (FDA) released a draft guidance for industry detailing processes and practices for inspections under its Bioresearch Monitoring ...

including Good Manufacturing Practice (GMP), Bioresearch Monitoring (BIMO), and 503B outsourcing facility inspections. Although participation in a remote evaluation will be voluntary, the guidance ...

The on-site inspection was conducted from 3rd March, 2025 to 7th March, 2025, by investigators from Bioresearch Monitoring Programme (BIMO) and Office of Study Integrity & Surveillance (OSIS) of US ...