FDA Extends CRADA with EduNeering for Inspection Training
EduNeering (Princeton, NJ, www.eduneering.com) and the Food and Drug Administration (Washington, DC, www.fda.gov) have extended their existing Cooperative Research and Developing Agreement (CRADA), originally formed in 1999, for five more years.
EduNeering (Princeton, NJ, www.eduneering.com) and the Food and Drug Administration (Washington, DC, www.fda.gov) have extended their existing Cooperative Research and Developing Agreement (CRADA), originally formed in 1999, for five more years. The original agreement was the first such CRADA formed between FDA and a private sector company. EduNeering’s ComplianceWire technology developed the Office of Regulatory Affairs’ virtual university (ORA U) to help train local, state, and federal regulators in a variety of subjects, including inspections, using course material supplied by the agency. The extension will expand learning solutions available for FDA employees and clients through new technologies developed since the original agreement was formed, including a virtual audit, which will allow users to “walk-through” their facilities and identify any potential problem areas or possible violations.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
