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...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Pharmacovigilance Auditing: Creating the Proper Structure & Tips for Success
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...
Accelerated the sNDA submission by 2 months with Automation in Narrative Writing
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...
FDA Draft Guidance on Demonstrating Substantial Evidence Shines a Light on Confirmatory Evidence in Clinical Trials
The FDA released a draft guidance in September 2023 regarding Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory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...
Change Management and Preparing for Computerized System Audits is Critical to Ensure Positive Regulatory Inspections
Change management in the pharmaceutical industry is Part 2 in our conversation on computer system validation (CSV). As discussed in Part 1, the increase in the use of automated manufacturing and quality systems is forcing an increased exposure on computer systems...
Clinical Data Science: Five Ways it Evolved from Clinical Data Management
Clinical data science is growing exponentially, as the Bureau of Labor Statistics confirms that the need for data scientists is rising faster than other areas with a 35 percent project growth rate through 2032. And, as the pharmaceutical industry has seen in the last...
Cell and Gene Therapies (CGT): 6 Detailed CMC Considerations for IND Submissions
BackgroundCell and gene therapies (CGT), often referred to as advanced therapeutic medicinal products (ATMPs), are rapidly emerging as favorable treatments, repeatedly targeting rare, ultra‑rare diseases and fall under regulators’ expedited programs [1]. To date, the...
Data Provenance in Real World Evidence Studies, Explained!
Data provenance in Real World Evidence (RWE) studies has quickly becoming an increasing focus in the industry, especially as 90% of pharmaceutical companies today have Real World Evidence teams according to Deloitte. If an audit is underway, for instance, consider an...
Patient Experience Data: An Important Consideration for FDA Benefit-Risk Assessments
From a drug development perspective, benefit-risk assessments can sometimes feel abstract. However, from a patient's perspective, they are a lived experience with a disease state and therapy. One benefit-risk assessment exists in paper and data, while the other lives...