Under RAPS

17 June 2013

NIH Opens up Supplement Labels to Public Researchers, Industry

By Alexander Gaffney, RF News Editor

Consumers and industry alike have long been able to look up the approved labeling for prescription medication using the US Food and Drug Administration's (FDA) Drugs@FDA online database. Starting [Read More...]

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17 June 2013

Global Networks Lead to Global Scandal as MHRA Defends Against Questionable Ranbaxy Practices

By Alexander Gaffney, RF News Editor

For years, regulators around the globe have been touting the challenges and benefits of globalization, explaining that a globally diverse product supply chain means needing to rely on regulatory [Read More...]

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17 June 2013

Supreme Court: 'Pay-for-Delay' Agreements May be Anticompetitive, But Aren't Presumed to be

By Alexander Gaffney, RF News Editor

In the second potentially landmark decision in as many weeks, the US Supreme Court has ruled that patent use settlements – more commonly referred to as "pay-for-delay" deals or reverse settlement [Read More...]

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17 June 2013

Congress Presses DEA to Open up on Regulatory 'Black Hole'

By Alexander Gaffney, RF News Editor

Once, professionals engaged in pharmaceutical regulatory affairs had only one agency to worry about: the US Food and Drug Administration (FDA), which has principal authority over whether a drug is [Read More...]

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17 June 2013

10 Takeaways From FDA's 2013 Warning and Untitled Letters: 10 - 6

By Alexander Gaffney, RF News Editor

Here at Regulatory Focus, we read a lot of the Warning Letters and Untitled Letters issued by the US Food and Drug Administration (FDA). In fact, we try to read every single one of them related to [Read More...]

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17 June 2013

Regulatory Reconnaissance (17 June 2013)

By Alexander Gaffney, RF News Editor

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US US lawmakers slam FDA over unused industry user fees (Pharma Times) Woodcock says FDA [Read More...]

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14 June 2013

Five in Focus | The War on Microbes, Plan B Finale, Orphan Drug Changes, Musical Chairs, and Device Hacking

By Alexander Gaffney, RF News Editor

Hello and welcome to a new  edition of Five in Focus, our Friday recap of the five most important, interesting, riveting or ground-breaking stories of the week. Regulatory Focus covers a lot of [Read More...]

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14 June 2013

AdvaMed Outlines Wishlist for New Changes to 510(k) Process

By Alexander Gaffney, RF News Editor

The system by which most medical devices reach the market, known as the premarket notification or 510(k) process, has been subject to a considerable amount of criticism in recent years, with [Read More...]

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14 June 2013

Regulators Again Look to Databases to Help Assess Safety of Adult, Pediatric Drugs

By Alexander Gaffney, RF News Editor

US regulators have issued a new call for proposals from private contractors in the hopes of being able to access data regarding the adults and pediatric utilization of drugs in inpatient and emergency [Read More...]

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14 June 2013

FDA Guidance Covers Clinical, Regulatory, Filing Considerations for Co-Developed Drugs

By Alexander Gaffney, RF News Editor

A new final guidance document released by the US Food and Drug Administration (FDA) seeks to clarify the scientific and regulatory factors that must be taken into consideration when developing two or [Read More...]

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