Latest News
|
17 May 2013
0 Likes 
Massachusetts U.S. Rep. Ed Markey has announced the reintroduction of legislation that he says is intended to open up clinical trial data, introducing a measure of transparency and bringing the US
Read More...
Latest News
|
16 May 2013
0 Likes
A new guidance document released by US federal regulators aims to establish best practices for conducting and reporting pharmacoepidemiologic safety studies that are conducted using electronic
Read More...
Latest News
|
24 April 2013
0 Likes
The US' Patient-Centered Outcomes Research Institute (PCORI), a budding comparative effectiveness research (CER) organization formed under the Patient Protection and Affordable Care Act (PPACA) of
Read More...
Latest News
|
24 April 2013
1 Likes
The European Medicines Agency (EMA) has announced the release of a new concept paper regarding the extrapolation of an experimental drug product's safety and efficacy data to other subgroups,
Read More...
Latest News
|
16 April 2013
2 Likes
A cornerstone of the global clinical trials ethical framework, the Declaration of Helsinki, has undergone a major revision and is now being released for public consultation, the World Medical
Read More...
Regulatory Update
|
15 April 2013
0 Likes
Clinical trial related issues account for four of the seven regulatory priorities announced by India’s Central Drugs Standard Control Organization (CDSCO), the country's drug regulatory authority, on
Read More...
Latest News
|
9 April 2013
0 Likes
A new "comprehensive analysis" conducted by the European Medicines Agency (EMA) has found that more than 60% of patients enrolled in pivotal trials submitted in support of drug applications—that is,
Read More...
Latest News
Regulatory Update
|
29 March 2013
0 Likes
India’s Drugs Controller General (DGC), in an order dated 26 March 2013, has convened a special committee to investigate allegations that the Central Drugs Standard Control Organization (CDSCO) did
Read More...
Latest News
|
21 March 2013
0 Likes
The EU and US regulatory approvals process by which pharmaceutical products used to treat chronic conditions get approved is lacking in rigor, argues a new paper published in the Public Library of
Read More...
Latest News
|
19 March 2013
1 Likes
A new report published by the Presidential Commission for the Study of Bioethical Issues calls for the US government to put into place a modified framework that will allow for researchers to conduct
Read More...