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Latest News | 17 April 2014

FDA Tightens Limits on Endotoxin Testing for Some Eye Surgery Devices

The US Food and Drug Administration (FDA) is warning manufacturers of intraocular ophthalmic devices that they must do more to reduce the risk of their devices being contaminated with the endotoxins Read More...


Latest News | 17 April 2014

When is a Live Case Presentation Promotional? FDA Draft Guidance Clarifies

A new draft guidance document published by the US Food and Drug Administration (FDA) is aimed at clarifying which information should be included in an investigational device exemption (IDE) Read More...


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...


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...


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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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