The systematic study of psychedelics in drug development programs is a relatively recent phenomenon with psychedelics currently under evaluation in clinical trials for the treatment of anxiety, depression, bipolar disorder, epilepsy, obesity, and substance addiction....

The PowerBI Dashboard has become the signature tool for clinical data analysis, and the growing dependence on PowerBI’s automated visualization tools has led to the need of dashboard validation. Clinical dashboards are built by ingesting raw data and transforming that...

Over the past several years, there has been a rapidly growing interest in applying Artificial Intelligence (AI) to nearly all sectors of the life sciences industry, especially in global medical writing. With its use in drug discovery1, clinical trial design2, and...

The US Food and Drug Administration’s (FDA) Knowledge-aided Assessment and Structured Application (KASA) review method is endeavoring to expand into drug substances. This is intended to support and address quality system related challenges that are related to New Drug...

Pharmacovigilance auditing is a critical function, as drug safety is a primary concern for pharmaceutical companies throughout the drug development lifecycle and beyond. Yet, the evaluation of drug safety is complicated due to safety monitoring requirements which...

In the dynamic and highly regulated pharmaceutical industry, time is often as critical as the quality of the submissions to health authorities. A leading US-based pharmaceutical company recently encountered a substantial challenge: submitting a Supplemental New Drug...

The FDA released a draft guidance in September 2023 regarding Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. They're accepting public feedback on this guidance until December...