Latest News
Regulatory Update
|
6 February 2013
0 Likes 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has submitted recommendations to the European Commission to amend the recently implemented EU pharmacovigilance legislation. In a
Read More...
Latest News
|
4 October 2012
0 Likes
The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) has released a new guideline for its internal review staff on how to handle amendments to generic drug applications.The Manual
Read More...
Latest News
Regulatory Update
|
25 September 2012
0 Likes
Australia’s Therapeutic Goods Administration (TGA) has announced planned amendments to the regulatory requirements for making minor variations to registered prescription drugs.Minor variations include
Read More...
Latest News
|
21 June 2012
0 Likes
The Food and Drug Administration Safety and Innovation Act (FDASIA) is set to be voted on in the Senate next week after receiving overwhelming approval from legislators in the US House of
Read More...
Latest News
|
20 June 2012
0 Likes
The US House of Representatives is preparing to vote on a piece of user fee legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA) as early as Wednesday, 20 June,
Read More...
Latest News
|
31 May 2012
0 Likes
The House of Representatives voted overwhelmingly to support the Food and Drug Administration Reform Act (FDARA), sending the bill to a conference committee for an ultimate merger with the
Read More...
Latest News
|
24 May 2012
170 Likes
BREAKING UPDATE: In a 96-1 vote, the US Senate has passed the Food and Drug Administration Safety and Innovation Act. The bill will now wait to be merged with the House of Representatives' version of
Read More...
Latest News
|
23 May 2012
0 Likes
The Food and Drug Administration Safety and Innovation Act (FDASIA) may have been deemed by Senate Majority Leader Harry Reid to be a “must pass bill,” but that hasn’t stopped a cavalcade of
Read More...