26 November 2013
By Katherine St. Martin
Twenty years have passed since progressive regulatory agencies first attempted to reverse discriminatory attitudes against inclusion of women in studies, yet today they remain underrepresented in medical areas responsible for the highest risk to the female population. This article explores the lingering issues behind the slow adoption of representative enrollment. [Read More...
18 September 2013
By Faraz Khan
Budding regulatory professionals may want to consider an internship during their university years to enhance their knowledge and improve their job prospects later on. Interestingly, few reports have been published on the subject of regulatory internships, so this personal account may help guide the undecided by providing insights on merits and downsides.
2 September 2013
By Moulakshi Roychowdhury, PharmD, JD
Let’s face it, regulatory advertising and promotion reviewers are generally not a technologically savvy demographic. Provided here is a brief review of three technology vendors that appear to provide optimal solutions to regulatory problems. [Read More...
14 August 2013
By Joy Frestedt, PhD, CCTI, RAC, FRAPS
The US Food and Drug Administration (FDA) is working to develop clarity around the in vitro
diagnostic (IVD) pathway at the same time its ability to regulate Laboratory Developed Tests remains under debate. FDA often identifies treatments rather than IVDs as “breakthroughs” on the market so the identification of “breakthrough” IVDs is not obvious. [Read More...
31 July 2013
By Barbara Leukers, DiplChem, RAC, and Priyanka Kothari, MS, RAC
Draft guidance issued by FDA on 22 February 2013 describes the agency’s thought process for distinguishing between product recalls and product enhancements and their associated reporting requirements. This new draft guidance document may raise new questions about reporting requirements and leave some regulatory loopholes that need to be addressed.
23 July 2013
By Christopher J.P. Velis
Inconsistency and ambiguity in the US Food and Drug Administration’s (FDA) regulatory process have created an environment of uncertainty in the medtech industry, stunting investment and slowing critical scientific advances. As a result of this confusion, investors are shy to support breakthroughs; the US risks losing its edge—and its market share—to regions with more fluid, predictable approvals. [Read More...
15 July 2013
By Mitchell Berger, MPH, RAC
This article provides an overview of statutory and regulatory provisions, policies and FDA guidance documents governing the timing of release of materials for Advisory Committee meetings. This review suggests that Advisory Committee materials subject to public disclosure should be publicly released further in advance of the Advisory Committee meeting. [Read More...
24 June 2013
By Meredith Brown-Tuttle, RAC
Medical writing and regulatory greatly rely on and closely relate to each other. It often is hard to enter either field expecting to be trained on “the basics,” since those vary by company, corporate culture, opportunities to learn and co-workers’ experience and willingness to mentor. Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics
by Linda Fossati Wood and Mary Anne Foote is a wonderful “proxy” mentor that covers the basics I wanted to know when I first entered the regulatory field. [Read More...
16 April 2013
By Atara Noiade, DOM, EAMP
Demand in the US for less-expensive pharmaceuticals has accelerated the controversial and illegal practice of drug reimportation by entities in other countries, whereby US-manufactured drugs, having been exported, are resold back to US consumers. Although reimportation gives people the opportunity to purchase pharmaceutical products at a significantly lower cost, reimported drugs, as well as those purchased online from other countries, currently have no guarantee of safety and may actually be expired or adulterated. Legislation of one aspect of drug reimportation, which would permit individuals to obtain their personal prescriptions via US-approved online foreign pharmacies, may provide a solution to the demand for less-expensive pharmaceuticals while ensuring their quality. [Read More...
22 February 2013
By Alan Minsk
In the last 12 months, the US Food and Drug Administration (FDA) has taken certain actions that, on their face, seem to be potentially limiting the benefits of orphan drug exclusivity (ODE). FDA’s actions are worth a review because they demonstrate that the once-sacrosanct ODE is not invincible. [Read More...