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.
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.
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.
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.
by Barbara Rusin, April 4, 2019
One of the first problems that clinical investigators may face when attempting to attain medical records is patient refusal to either provide them, or allow them to be collected. At the outset of such a refusal, any potential study subject should educated as to how important medical histories are to research studies.
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.
by Barbara Rusin, March 7, 2019
In defining the barriers to access to historical medical records, it is important to first recognize that some potential study subjects will come with no obstacles to medical history availability, while other may present a combination of issues which must be tackled.
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…
Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?
by Barbara Rusin, February 21, 2019
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, a CRO, or a study sponsor, but all are detrimental to the research in some form.
by Staff writer, February 14, 2019
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.