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Latest News | 15 April 2014

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps?

Regulatory Focus' ongoing series of Regulatory Explainers takes complicated regulatory topics and makes them simple enough for anyone to understand.In our latest Regulatory Explainer, we are taking a Read More...


Regulatory Update | 15 April 2014

Brazil Expedites Device Imports

Brazil’s national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing Read More...


Latest News | 15 April 2014

FDA Using Twitter, Telenovelas and Translations to Reach Non-English Speakers

If you're reading this article, chances are good you take something for granted every day: your ability to read. But even beyond that, the fact that you're reading Regulatory Focus means you're Read More...


Latest News | 15 April 2014

Regulatory Reconnaissance: US Official: Overseeing Safety of APIs a "Hopeless Task" (15 April 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org. Focus is putting together an Read More...


Latest News | 14 April 2014

EMA Tries to Clamp Down on Revolving Door of Regulators

EU regulators have released a new "best practices" guide intended to steer the European Medicines Agency (EMA) clear of the types of perceived conflicts of interest that plagued the agency's former Read More...


Latest News | 14 April 2014

FDA Loosens Regulatory Controls on Stair-Climbing Wheelchairs

The US Food and Drug Administration (FDA) has decided to down-classify stair-climbing wheelchairs from class III to class II medical devices, meaning they will no longer require premarket Read More...


Latest News | 14 April 2014

ICH Looks to Clarify 'Key Issues' With E2C Adverse Event Reporting Guideline

In 2012, the International Conference on Harmonisation (ICH) released a new guideline, E2C (R2) – Periodic Benefit-Risk Evaluation Report, meant to ensure that PBRERs—standardized adverse event Read More...


Latest News | 14 April 2014

Regulatory Reconnaissance: Can FDA's Regulatory Processes be Improved? (14 April 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org. Focus is putting together an Read More...


Latest News | 11 April 2014

FDA Formally Withdraws Approval for Second Generic Version of Popular Antidepressant

This week the US Food and Drug Administration (FDA) formally—and quietly—withdrew a generic version of GlaxoSmithKline's Wellbutrin XL (bupropion) 300 mg following a determination that the drug was Read More...


Latest News | 11 April 2014

EMA Initiates Review of Low-T Medications

The European Medicines Agency's (EMA) has announced it will initiate a review of testosterone-containing medicines following concerns that the drugs, used primarily to treat a condition commonly known Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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