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. [
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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. [
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24 January 2013
By Edye Taylor, JD, MA, CIP
To better understand potential pitfalls when non-Western institutions must comply with US regulations governing research misconduct, it’s important to understand a brief historical background on how US institutions began developing research misconduct policies and what role US federal agencies play in enforcement. [
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27 November 2012
By Teffany Hutto, RAC
Time and time again within companies, regulatory departments have been known as roadblocks to progress, sometimes due to a lack of understanding about the regulatory process. Here are some suggestions that helped me to shed the negative image some of my colleagues had of regulatory.
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18 October 2012
By Ron Warren, RAC
The outcome of any US Food and Drug Administration (FDA) submission is never a certainty, but sponsors can enhance their chances of success by optimizing the submission strategy and content, and by minimizing or avoiding the potential submission problems that tend to slow down or prevent the completion of premarket reviews. [
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18 October 2012
By Ron Warren, RAC
From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. But the US Food and Drug Administration (FDA) has been besieged by critics who claim the agency is a hindrance to innovation and a threat to the US med-tech industry. Are they right? [
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17 July 2012
By Michael Leigh, RAC
Regulatory professional Michael Leigh, RAC, says he's surprised at how many professionals try to impress others with complexity. Instead, says Leigh, company procedures should provide structure and guidance for decision making that stresses simplicity. [
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26 June 2012
By Michael Gross, PhD, RAC
This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, it discusses industry’s response to FDA’s proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and related guidance. [
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26 June 2012
By David Virgo BSc, MSB
Can rodent carcinogenicity testing, current mandated by the International Conference on Harmonisation (ICH) Steering Committee, be eliminated in the majority of cases? David Virgo isn't convinced it can be, and describes the challenges facing the proposal in this Perspectives article. [
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16 April 2012
By Diane R. Whitworth, MLS
Alliances between the pharmaceutical industry and contract research organizations (CROs) have evolved over the past three decades from transaction-based relationships to truly collaborative strategic partnerships. Although the traditional fee-for-service outsourcing model still exists, an increasing number of pharmaceutical companies and CROs have formed enduring partnerships. [
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