Latest News
|
4 April 2013
1 Likes 
A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user
Read More...
Under RAPS
|
2 April 2013
6 Likes
The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an EMA requirement and will soon be required by FDA, so anyone working on drug regulatory submissions needs to understand the format well.
Read More...
Latest News
|
27 March 2013
0 Likes
A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the
Read More...
Latest News
|
21 March 2013
0 Likes
The US Senate has approved a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees
Read More...
Latest News
|
8 March 2013
0 Likes
The US Food and Drug Administration (FDA) has released a new congressional report it wrote regarding its performance under the final fiscal year of the Medical Device User Fee Act (MDUFA), a law
Read More...
Latest News
|
5 March 2013
0 Likes
Legislators have introduced a piece of legislation in the US House of Representatives that would allow the US Food and Drug Administration (FDA) to spend user fees that it had previously been able to
Read More...
Latest News
|
15 February 2013
0 Likes
US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius has quietly confirmed what many in the industry have long known: User fees paid to the US Food and Drug Administration
Read More...
Latest News
|
19 December 2012
0 Likes
When it comes to the review of medical devices, how do you think the US Food and Drug Administration (FDA) is doing? While the question is usually left to be answered in the opinion pages of trade
Read More...
Latest News
|
28 November 2012
0 Likes
The US Food and Drug Administration (FDA) is making it a whole lot easier to keep track of the agency’s planned activities and projects coming out of the FDA Safety and Innovation Act (FDASIA), a
Read More...
Latest News
|
5 November 2012
4 Likes
Hurricane Sandy left much of the US' eastern seaboard battered and flooded after coming ashore in late October, and the damage and delays it caused are having regulatory implications, the US Food and
Read More...