12.08.22 -- Regulatory Considerations Of Drug Abuse Potential Investigations

While working for BMS, Ian Walters noticed a disturbing trend in the industry. Big Pharma companies would often lament that small biotech firms do not develop drugs the same way it is done at large companies. He is now working to change the biotech model.

New government disclosure regulations are emerging. Regulations from public health organizations around the globe have increased administrative compliance tasks and driven up the consequences of noncompliance. 

As the CRO industry grows rapidly, many companies outpace the capabilities of their software tools. Discover why financials, project management, reporting, compliance, and other areas of the business become more demanding because of this.

We have created a flexible sourcing approach that gives operational teams the benefit of our clinical research expertise and access to our extensive resources. Our functional service provider (FSP) model lets you control and finetune your level of involvement so you have full flexibility in deciding how hands-on (or hands-off) you want to be.

We support our corporate sponsors by providing both assessment and processing of SUSARS as per local and country requirements. We provide reliable reporting of adverse events, unbiased signal detection, and potential mitigation and risk management plans, based on any findings as requested. 

This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.

Discover how a biotech company was assisted when it could not afford the time and expense of conducting studies recommended by another of its consultants and agreed to by the FDA.

This white paper highlights the key principles set forth in E8(R1), which was endorsed in May 2019, and E6(R3), which is scheduled for publication in late 2022, illustrating how sponsors and contract research organizations (CROs) can achieve compliance.

With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug. Find out the results in this case study.

The gig economy has exploded in popularity over the last decade, thanks in part to the Great Recession. In this article, delve into a way to apply the gig economy model to GxP auditing.

If a medicine’s sponsor wants to maximize the impact of the product on patients, providers, and their own bottom line, the need to proactively make regulatory affairs part of the lifecycle planning strategy is critical to the planning process.

Strategically transform your medical review, safety review, and compliance monitoring processes with our innovative solution for Pharmacovigilance.