Tag Archives: FDA

Sequestration: What Does it Mean for Pharma?

By Guest Blogger | Published: October 3, 2012
You may have read horror stories about the looming Sequestration Act, but what exactly is it? And what does it mean for US pharma? Tom Norton reports. Lurking in the shadows of the US General Elections is something called The Sequestration Transparency Act of 2011. Of late, you may have read the occasional article that breathlessly [...]
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Budget policies jeopardize FDA funding, user fees

By Guest Blogger | Published: September 25, 2012
Budget policies jeopardize FDA funding, user fees Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA), efforts to cut the federal deficit raises questions about how those fees will be collected and used in the coming year. FDA, [...]
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The Food and Drug Bar Travels to Brazil

By Guest Blogger | Published: September 25, 2012
The Food and Drug Bar Travels to Brazil By: Frederick R. Ball Partner, Duane Morris LLP From September 9-12, , members of the U.S. food and drug law bar met with their Brazilian counterparts for the Food and Drug Law Institute’s conference “U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device & Food Law & Regulation” in [...]
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FDA, AdvaMed Seeking Clarity on Med Device Pre-Market Approvals

By Guest Blogger | Published: September 5, 2012
by Elizabeth Hollis The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to [...]
Posted in FDA, Guest Blog, IP, Legal, Manufacturing, Market Access, Meetings, Regulatory, Safety, Strategy, Technology | Also tagged | 1 Comment

Public Interest in Private Science: New Pathways to Measuring R&D Success

By William Looney | Published: August 8, 2012
Today’s big product story — the apparent end to a decade-long drought in the drug development pipeline — is the prep stage for tomorrow’s big policy question:  are industry R&D priorities in synch with the changing burden of disease?
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