Latest News
|
12 April 2013
0 Likes 
The US Food and Drug Administration (FDA) has announced its adoption of the International Conference on Harmonisation's (ICH) M7 draft guideline on the assessment and control of mutagenic byproducts
Read More...
Latest News
|
4 April 2013
0 Likes
EU regulators are preparing a new guideline to assist companies in the development of treatments for Autism Spectrum Disorder (ASD), a collective term referring to the wide range of disorders that
Read More...
Latest News
|
1 February 2013
0 Likes
The European Medicines Agency (EMA) has released a draft scientific guideline on the development of biosimilar low-molecular-weight heparins, a type of medical product often used in surgical settings
Read More...
Regulatory Update
|
18 January 2013
0 Likes
The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued a draft guideline on the diagnosis and management of chronic hepatitis B in children,
Read More...
Latest News
|
15 January 2013
0 Likes
The European Medicines Agency (EMA) has released an updated scientific guideline it says will make it easier for sponsors of oncology and other anticancer medicines to conduct clinical trials.The
Read More...
Latest News
|
3 December 2012
0 Likes
Just weeks after releasing draft guidelines on a new recall system, India's Central Drugs Standard Control Organization (CDSCO) has finalized its recall and rapid alert system for chemical and
Read More...
Latest News
|
3 December 2012
0 Likes
The European Medicines Agency (EMA) has released a new guideline to instruct sponsors of clinical trials on best practices for assessing antibody-based products used to prevent the hepatitis B
Read More...
Latest News
|
19 November 2012
1 Likes
The US Food and Drug Administration (FDA) has announced its adoption of the International Conference on Harmonization's Q11 guideline on the development and manufacture of biological and chemical
Read More...
Latest News
|
1 November 2012
0 Likes
The European Medicines Agency (EMA) has released a new concept paper calling for revisions to the way osteoporosis products are evaluated in the EU, saying existing guidelines are largely inadequate
Read More...
Latest News
|
1 November 2012
0 Likes
India's Central Drugs Standard Control Organisation (CDSCO) has released a new draft guideline on a new recall and rapid alert system for chemical and biological drug products, bringing it more
Read More...