As the FDA explores the complexities of using real-world data to provide evidence for regulatory decision-making, sponsors face the challenge of staying updated with the evolving definitions and standards. Recently, the FDA released its finalized "Guidance for...
Recently, there’s been notable attention within the pharmaceutical industry regarding the European Medicines Agency (EMA) and its decision to restart the clinical data publication process, termed “EMA Policy 0070”. Slated to commence in an EMA Board meeting in...
Understanding FDA meetings has become clearer and more exciting with the introduction of the 'Type D' meeting format under PDUFA VII. Introduced on October 1, 2022, this new format is designed to make specific interactions between sponsors and the FDA faster and more...
In today's fast-paced world, the blend of technology and human expertise is transforming various industries, including Clinical Research Organizations (CROs). At MMS, we lead this change, tapping into state-of-the-art technology while valuing the unmatched role of...
The Vital Role of Regulatory Strategists, Biostatisticians, and Clinicians in Protocol Development Recently, there's been a growing focus on using single-arm trials as primary evidence for drug authorization in the European Union (EU). Given this, the role of...
A clinical study report (CSR) describes the conduct and results of an individual clinical trial. The CSR is a component of regulatory submissions (i.e., the Common Technical Document) and is essential for ultimate approval. Lean CSR writing is ‘focused writing,’...
On May 16th, 2023, EMA conducted a much-awaited webinar to address the phased restart of EMA Policy 0070 after almost five years of suspension. The restart will come into effect in September 2023. The EMA initially introduced the clinical data publication Policy 0070...
The role of Quality Assurance (QA) in outsourcing is important for sponsors to reduce business risk, time and effort. In the pharmaceutical industry, vendors can support any aspect of the product's manufacturing, testing, labeling, or distribution. However, the...
Are you working on annual submissions that utilize the current FDA Annual Report format? Are you concerned about the mandatory adoption of the FDA DSUR (development safety update report)? Below are five reasons to embrace the change and place the DSUR at the center of...