6 December 2018 - The health care system is integrating more effective ways to leverage electronic tools to gather and use ...
6 December 2018 - One challenge we face right now, when it comes to developing diagnostics that can help target ...
4 December 2018 - The US FDA has published final guidance for the generics industry on post-complete response letter meetings. ...
30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...
30 November 2018 - EMA has published a PDF revision of its guideline on the environmental risk assessment ...
6 November 2018 - At one time, Avandia (generic name: rosiglitazone) was a major diabetes drug for GSK with sales exceeding ...
18 October 2018 - Too many Americans struggle with the high cost of drugs. In some cases, patients go without ...
16 October 2018 - FDA Commissioner Scott Gottlieb highlighted minimal residual disease's potential as a surrogate endpoint in clinical trials ...
13 September 2018 - The U.S. FDA today announced a new set of product-specific guidances to support industry in identifying ...
22 August 2018 - As we all work to confront the staggering human and economic toll created by the opioid crisis, ...
15 August 2018 - Health Canada recently released for consultation a plan to establish a mechanism that allows for the ...
3 August 2018 - As a public health agency, there is no greater impact we can have to improve the ...
25 July 2018 - In an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” ...
20 July 2018 - One of the ways that the U.S. FDA is working to address the opioid epidemic is ...
20 July 2018 - The U.S. FDA today announced a new batch of product-specific guidances to support industry in identifying ...