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Latest News | 24 April 2014

New Patient-Focused Drug Development Meeting to Concentrate on Neurologic Disorders

Since the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, the US Food and Drug Administration (FDA) has been publicly meeting with patients who suffer from Read More...


Latest News | 24 April 2014

FDA's Proposal to Cut Down on Risks Listed in Drug Ads Wins Praise From Drug Companies

In February 2014, the US Food and Drug Administration (FDA) announced that it wanted to revisit how it regulates the "major statement" of its drug advertisements, calling them potentially too long, Read More...


Latest News | 24 April 2014

Report Finds Huge Variations in CDER Performance, but Few Explanations as to Why

New research published by the Manhattan Institute for Policy Research (MIPR), a right-leaning think tank which focuses in part on pharmaceutical regulation policy, indicates that there are wide gaps Read More...


Latest News | 24 April 2014

FDA's Frozen Poop Problem

Researchers have announced a breakthrough that may make it even easier to treat patients infected with Clostridium difficile (C. diff) using a novel but controversial technique involving fecal matter. Read More...


Latest News | 24 April 2014

Regulatory Reconnaissance: FDA, EMA Working on Biosimilar Data Guidance (24 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 | 23 April 2014

New FDA Guidance Tries to Define When Antibody Products are 'The Same'

A new guidance document released this week by the US Food and Drug Administration (FDA) aims to clarify the interaction of the 2012 Biologics Price Competition and Innovation Act (BPCI) and the 1983 Read More...


Latest News | 23 April 2014

DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA

The US Food and Drug Administration (FDA) is getting some new, though not unexpected, authority this week by way of its parent organization, the US Department of Health and Human Services (DHHS). The Read More...


Latest News | 23 April 2014

Are Products Used to Whiten Your Teeth Drugs or Cosmetics? FDA Weighs in

When is a tooth whitener a cosmetic, and when is it a pharmaceutical or medical device product? The question has never had a clear regulatory answer, and despite the efforts of the American Dental Read More...


Latest News | 23 April 2014

House Legislators Want FDA to Discuss 'Alternatives' to Generic Labeling Rule

A large group of House Republicans is once against raising questions about the US Food and Drug Administration's development of a rule that would change the way generic drug labels are regulated, Read More...


Latest News | 23 April 2014

Regulatory Reconnaissance: AdComm Pans MoxDuo as Massachusetts Limits Zohydro (23 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...


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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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