The 505(b)(2) is a New Drug Application (NDA) containing full reports of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
FREE DOWNLOAD: Lay Summary Whitepaper
This complimentary lay summary whitepaper will explain: the ins and outs of lay summary writing, the importance of starting a pilot program, a checklist for lay reviewers, and strategic advice for becoming more transparent. Click on the image for the full...
Being Inclusive, the Open Door Policy, and True Success: A Conversation with Diederik Van Niekerk
In this Expert Insights interview, we sit down with our South African leadership, Diederik Van Niekerk, Operations Manager at MMS in Bloemfontein, South Africa, to discuss his detailed approach for effective team-building, his views on work/life balance, and growth....
Part 4: The Case for Better Health History Records – Overcoming Barriers to Medical Records Access
In Part 3 of this medical histories series, the focus centered on defining many of the barriers that clinical investigators face when attempting to procure adequate medical records for subject eligibility determination. While the list of potential issues appeared...
PhUSE: Retrospective vs. Proactive Anonymization of Narratives
Exerpt from whitepaper originally published by PhUSE on March 14, 2019 by project co-leads – Rashmi Dodia, MS, RAC and Gregory Campbell, BS Executive Summary Ever since policy 0070 was first introduced in 2016, there have been continuing concerns and challenges among...
Part 3: The Case for Better Health History Records – Identifying Barriers to Access
In Part 2 of this series, the focus was on ensuring adequate information to support subject eligibility. Knowing how many and what kinds of records to review is key to developing a robust review program to ensure subject eligibility, as is knowing how to reconcile...
How #OneMMS Actively Supports Rare Disease Day
Rare diseases are often overlooked, but they affect many individuals. There may be as many as 7,000 rare diseases affecting approximately 25-30 million people in the US alone, according to the National Institutes of Health (NIH). Rare diseases are defined as...
Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?
Part 1 of this medical histories series focused on the regulations relevant to clinical trial subject eligibility, and the possible issues which can arise when ineligible subjects are enrolled. As noted, the outcomes vary depending on whether you are a clinical site,...
Regulatory Strategy, 505(b)(2) Applications, and Chess: A Conversation with Ben Kaspar
In this Expert Insights interview, we sit down with Ben Kaspar, Global Submissions Manager at MMS, to discuss regulatory strategy, 505(b)(2) applications, and general submission advice for any global companies outside of the US that plan to submit to the FDA. In...