Expert Insights

Part 2: 505(b)(2) NDA – The Importance Early-Stage Planning

by Ben Kaspar, May 23, 2019
The unique aspects of the 505(b)(2) submission structure and label claims are perhaps best illustrated at the pre-IND planning stage. Whereas for a new chemical entity, pre-IND discussion is generally focused on the determination of a safe starting dose in humans, the 505(b)(2) discussion will be focused around unsupported label claims and getting FDA agreement on the plan to address those claims in clinical development.

Part 1: 505(b)(2) NDA – Navigating the Regulatory Pathway

by Ben Kaspar, May 16, 2019
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 right of reference for use.

FREE DOWNLOAD: Lay Summary Whitepaper

Kasim McLain, et al, May 9, 2019
This 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.

Being Inclusive, the Open Door Policy, and True Success: A Conversation with Diederik Van Niekerk

by Staff writer, April 11, 2019
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. Diederik’s leadership and excellent insights has strengthened MMS South Africa and he is an award-winning executive business coach in his own right.

PhUSE: Retrospective vs. Proactive Anonymization of Narratives

by PhUSE, March 14, 2019
This White Paper focuses on two approaches to produce anonymized narratives – retrospective and proactive. The retrospective section sheds light on the challenges faced with qualitative methods like redaction and what impact it has on data utility. The second part of this White Paper offers a perspective on proactive anonymization and how to operationalize it.

How #OneMMS Actively Supports Rare Disease Day

by Staff writer, February 28, 2018
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 conditions that affect fewer than 200,000 people…


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