News

Search:
 Search

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...


Latest News | 22 April 2014

FDA Offers New Ideas for Transparent Approach Toward Regulatory Enforcement

Here at Focus, we read regulatory enforcement documents like it's our job. To be fair, understanding what the US Food and Drug Administration (FDA) is doing and why is our job.But despite having read Read More...


Latest News | 22 April 2014

America's (Other) Most Wanted: FDA Takes Aim at Drug and Device Fugitives

The US Food and Drug Administration (FDA) is taking a page from the Federal Bureau of Investigation (FBI) in the hopes of tracking down some of the most egregious violators of federal food and drug Read More...


Latest News | 22 April 2014

FDA Looks for Stakeholder Input on Trials Meant to Assess Abuse of Opioids

The US Food and Drug Administration (FDA) has experienced no shortage of criticism in recent years about its regulation of opioid-based painkillers in light of the drugs' contribution to what the Read More...


Latest News | 22 April 2014

FDA Launches Long-Awaited Expedited Approval Program Aimed at High-Need Devices

The US Food and Drug Administration (FDA) has released a long-awaited draft guidance document outlining an expedited approval pathway that can be used by sponsors of medical devices intended to treat Read More...


Latest News | 22 April 2014

Regulatory Reconnaissance: Lilly's Potential Blockbuster Gets FDA Approval (22 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...


1 2 3 4 5 6 7 8 9 10 ... 342
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


New Regulatory Focus Apps for iPad and iPhone