general regulatory

General Regulatory covers the frameworks and processes organizations use to comply with global laws and industry standards. Understanding regulatory expectations is essential for managing risk and maintaining product quality. This collection of articles discusses practical strategies for staying ahead of changing regulations.
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Quality & Compliance

FDA Publishes over 200 Complete Response Letters (CRLs)

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...

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Regulatory Sciences

Omnichannel Marketing in Pharma: A Strategy Guide for Regulatory Compliance

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...

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Regulatory Sciences

CMC Expectations During Drug Substance Transfer from Ex-US Manufacturers

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...

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Regulatory Sciences

Advancing Digital Transformation in Medicines: EMA's Successful ePI Pilot

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...

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Regulatory Sciences

FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know

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...

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Regulatory Sciences

Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions

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....

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Regulatory Sciences

FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program Overview

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...

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Regulatory Sciences

Navigating FDA's Q-Submission Process: A Strategic Advantage for Medical Device Developers

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...

Regulatory Sciences

Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development

Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track The FDA has recently undergone a wave of layoffs that are beginning to...

Regulatory Sciences

Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance

The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food...

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