MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
What is FDA’s Project Renewal? The Modernization of Decades Old Oncology Drug Labels
Project Renewal is an initiative established by the FDA to reassess outdated oncology drug products and modernize them. The Oncology Center of Excellence (OCE) recently approved a labeling update for Genentech’s capecitabine tablet, known as Xeloda. In this labeling...
FDA Updates IND Expanded Access Guidance for Industry
New recommendations for IRB review, informed consent and expanded access policies. FDA recently announced the availability of a revised draft Guidance for industry on expanded access (EA) to investigational new drugs (INDs) for treatment use, which consists of...
What is Regulatory Information Management System (RIMS)?
Regulatory Information Management Systems Software (RIMS) are centralized platforms designed to support and streamline Regulatory Affairs teams and operations. RIMS helps in the creation, organization, submission, and archival of regulatory information in regulated...
Aligning a Global Team, Engaging Colleagues, and the Importance of a Human Connection: A Conversation with Daria Fellrath
In this blog, we sat down with Daria Fellrath, Senior Manager of Global Talent and Culture Management at MMS, to discuss how important it is to align a global team, engage with colleagues, and foster human connections across organizations. Daria’s leadership and...
MMS Named a Great Place to Work in India
BANGALORE, India (1/12/2023) – MMS Holdings, a data-focused contract research organization (CRO), has been named a Great Place to Work by the Great Place to Work Institute of India. This award is based on anonymous feedback from a survey sent out to employees and...
Clinical Trial Information System (CTIS) Updates: Cross-Functional Teams are Needed for Success
The Clinical Trials Information System (CTIS) is a single portal for European Union (EU) competent authority and ethics submissions for clinical trial applications (CTAs) across EU member states. The system represents the actualization of the EU Clinical Trials...
A Step-by-Step Approach to Determining Company Confidential Information (CCI) in Redaction Proposal Packages
With all new regulations like Health Canada-PRCI, EMA Policy 0070 and EU-CTR requiring the publication of clinical information, it’s important to understand what is considered company confidential information (CCI) and how to protect the information being shared with...
Exploring the use of Real-World Evidence in Regulatory Decision Making Under PDUFA VII
The PDUFA VII Commitment Letter builds on the programs supporting the use of Real-World Evidence (RWE) in regulatory decision-making begun under PDUFA VI. Specifically, the following initiatives incorporating RWE have been incorporated into PDUFA VII: Pilot Advancing...
Updates to FDA Meetings under PDUFA VII
Sponsors receive FDA feedback and advice on their drug development program via formal FDA meetings. These meetings allow Sponsors to learn the FDA's current thinking on a specific topic and to amend their development program based on FDA's recommendations...
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