Quality & Compliance
On July 10th, 2025, the FDA announced its decision to publish over 200 Complete Response Letters (CRLs) issued between 2020 and 2024. This decision marks a seismic shift in the way our industry...
Regulatory Sciences
As emerging marketing technologies rapidly evolve and reach maturity, marketers can now unlock sophisticated new tools to more efficiently and effectively reach consumers. As always, marketers remain...
Regulatory Sciences
Regulatory Drivers for US-based API Manufacturers Recent shifts in US tariff policies have introduced new pressure points in the global pharmaceutical supply chain, particularly for manufacturers...
Regulatory Sciences
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have recently concluded a successful pilot project on electronic product information (ePI), marking a significant...
Regulatory Sciences
A New Era of FDA Disclosure On Thursday, July 10, 2025, FDA published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications...
Regulatory Sciences
For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program....
Regulatory Sciences
An inside look at FDA's new Commissioner's National Priority Voucher (CNPV) pilot program—what it is, why it matters, and how regulatory and development teams can leverage it to accelerate...
Regulatory Sciences
In the highly regulated medical device industry, navigating FDA's submission process can be daunting, especially for start-ups. However, FDA's Q-Submission (Q-Sub) program offers a valuable...