Resources

In the highly regulated pharmaceutical industry, compliance with FDA regulations is paramount to ensuring product safety and overall quality. When a large pharmaceutical company received a Form FDA 483 and...

Susan 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...

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the...

In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and several other experts will provide brief...

As regulatory processes evolve, the Knowledge-Aided Assessment and Structured Application (KASA) system is set to transform FDA application reviews through automation and structured data analysis. Designed to enhance efficiency and...

Regulatory policies in the MedTech and pharmaceutical industries often shift with new administrations. With the current administration proposing sweeping changes, including deregulation, updates to FDA structure and processes, and tariff...