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Latest News | 17 April 2014

Regulatory Reconnaissance: Endo Hit With New Warning Letter (17 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 | 16 April 2014

"Our Lady's Tears" Brings Warning Letter to Supplement Maker

If you didn't know better, seeing an ingredient on a dietary supplement labeled as "Our Lady's Tears" might make you think the manufacturer's process involved forcing a woman to cry into a batch of Read More...


Latest News | 16 April 2014

Industry Sees Much not to ‘Like’ in FDA's First Social Media Guidance Document

In January 2014, the US Food and Drug Administration (FDA) released the first of what it said would be many guidance documents intended to clarify the use of social media by life sciences companies. Read More...


Latest News | 16 April 2014

In Wake of Compassionate Use Debate, New Bill Promises Wider Access to Drugs and Devices

New legislation introduced in the US House of Representatives this week would allow for the import, manufacture and sale of investigational drugs and devices meant to treat terminally ill Read More...


Latest News | 16 April 2014

EU Regulators Warn of Counterfeit Copies of Cancer Drug Herceptin

EU regulators have issued a warning that several batches of the cancer medicine Herceptin (trastuzumab) have been "tampered with," falsified and reintroduced into the supply chain, potentially putting Read More...


Latest News | 16 April 2014

Regulatory Reconnaissance: Court Finds State Painkiller Ban Unconstitutional (16 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 | 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...


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...


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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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