51ÁÔÆæ

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at 51ÁÔÆæ, 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...

The new US Presidential Administration could bring significant impact on MedTech and pharmaceutical regulations for manufacturers and product developers. Join our expert panel of scientists and FDA consultants as they...

For companies operating in FDA-regulated industries—such as pharmaceuticals, medical devices, and biotechnology—FDA inspections are an inevitable and crucial part of maintaining compliance. Understanding the inspection process and preparing adequately can...