Latest News
|
9 May 2013
0 Likes 
Congressional legislators have nearly cleared a new piece of legislation that would reauthorize the US Food and Drug Administration (FDA) to collect and spend user fees to facilitate and expedite the
Read More...
Latest News
|
9 May 2013
0 Likes
The European Medicines Agency (EMA) has announced that it will, starting immediately, be instituting new changes meant to simplify the process by which fees for orphan medicine applications are paid
Read More...
Latest News
|
9 May 2013
1 Likes
What comes to mind when you think about federal agencies that affect healthcare product regulation? If you're like many, the first agency to come to mind is the US Food and Drug Administration (FDA),
Read More...
Latest News
|
9 May 2013
0 Likes
What is an investigation drug worth? In a philosophical sense, an investigational drug may be priceless to a patient facing the prospect of certain death, offering them additional time, reduced
Read More...
Latest News
|
9 May 2013
0 Likes
A new draft guidance document released by the US Food and Drug Administration (FDA) aims to clarify details regarding so-called "expanded access" to pharmaceutical therapies that are currently being
Read More...
Latest News
|
9 May 2013
0 Likes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US FDA Saving the Pharma Industry With Faster Drug Approvals (Reuters) House Panel Approves
Read More...
Latest News
|
8 May 2013
0 Likes
One of the biggest regulatory news stories of 2011 revolved around the issue of drug shortages, the outcome of a multitude of unfortunate circumstances that had the effect of causing many drugs—and in
Read More...
Latest News
|
8 May 2013
2 Likes
What comes to mind when you think about federal agencies that affect healthcare product regulation? If you're like many, the first agency to come to mind is the US Food and Drug Administration (FDA),
Read More...
Latest News
|
8 May 2013
0 Likes
A recent guidance document released by the US Food and Drug Administration (FDA) that aims to standardize the process for reporting periodic safety update reports to regulators is winning strong
Read More...
Latest News
|
8 May 2013
0 Likes
The US Food and Drug Administration (FDA) plans to hold a public meeting in June 2013 to discuss its progress in advancing regulatory science for generic drug products and solicit feedback on its
Read More...