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Alexander Gaffney
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Alexander Gaffney

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When drugs are being reviewed by regulators, they are assessed for what risks they might pose to consumers. Those risks, once identified, can be dealt with in one of three ways: They can be designed out of the drug through a reformulation or the use of new excipients, consumers can be made aware of the risk through labeling, or consumers can be restricted from accessing the drug in an attempt to mitigate the risks.

But what if a fourth option—the elimination of the risk outside of the drug—was available?
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Alexander Gaffney

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Regulatory Reconnaissance (26 February 2013)

Good morning, and welcome to another edition of Regulatory Reconnaissance. The sequester comes into effect on Friday, and Steven Grossman of the group Alliance for a Stronger FDA says FDA stands to lose about $210M from its budget because of it.

In the US, FDA approves Stivarga for GI tumors and a new cattle drug, industry groups are panning parts of a CDER draft guidance on electronic submissions, and Medtronic has won expanded approval for its Resolute Integrity stent. Abroad, the EC meets today to start working on a medical device regulatory framework, VICH is out with new guidelines, India's trial approvals rate has fallen by 50% in two years, and MHRA is warning of a risk of fracture associated with Amgen's bone drug Prolia.
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Alexander Gaffney

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Hamburg: Quality one of FDA's 'Highest Priorities' in 2013, Agency Creating New Quality Office


In a wide-ranging speech before the Generic Pharmaceutical Association's annual meeting in Florida, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her regulatory agency will be placing an increased focus on quality issues in 2013, noting its integral role in recurring drug shortages and other problems.

The generics industry, Hamburg said, is "playing an increasingly central and transformative role in our nation's health care system," adding that 85% of all prescriptions filled in the US are generics.

But even as it steps up to the plate to provide huge savings to the American consumer—by Hamburg's estimation, more than $1 trillion since the passage of the Hatch Waxman Act—it's regularly falling short in one area of particular concern: Quality.
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Alexander Gaffney

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FDA Censures Company for 'Liking' Unapproved Claim on Facebook

The US Food and Drug Administration (FDA) doesn't like it when a company "likes" an unapproved claim regarding its product on Facebook, according to a recent Warning Letter sent to supplement marketer AMARC Enterprises.
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FDA Draft Guidance Aims to Clarify Difference between Recalls and Removals


When is a recall not really a recall? Between the US Food and Drug Administration (FDA) and industry, this has long been a point of contention.

On 21 February 2013, FDA released a new draft guidance document aimed in part at establishing the requirements for distinguishing between defect- or failure-based recalls and products recalled for improvements.
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Have him in circles
64 people
Danny Page's profile photo
Ken Liu's profile photo
Chris Tocco's profile photo
David Waterhouse's profile photo
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  • Regulatory Affairs Professionals Society
    2010 - present
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Writer of News for Regulatory Focus.
Introduction
By day, I'm the news editor for Regulatory Focus, a trade publication interested in all things healthcare product regulation. From pharmaceutical to medical devices, biotech to supplements and everything in between, it interests me. 

Check out my work at RegulatoryFocus.org, or on Twitter at @AlecGaffney.
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