US FDA updates guidance on treatment-emergent suicide risk in trials
The US FDA has revised its draft guidance on suicide risk in trials with updated terminology and expanded assessment criteria and has called for drug industry feedback.
Archives for August 19, 2012
GSK to close Indian API plant and turn to third-party contractors
GSK tells in-Pharmatechnologist.com that decision to close Indian API plant was prompted by rising cost of manufacture and availability of third party contractors.
SFDA to keep a public blacklist of pharma manufacturing offenders
The SFDA will name and shame companies and individuals responsible for violations of drug and medical device laws in a public blacklist.
BASi sees revs and gross profits fall in Q3 but upbeat about prospects
Preclinical CRO Bioanalytical Systems (BASi) saw revenue, margins and gross profits fall during its fiscal third quarter but the firm is positive about the impact of recent restructuring efforts.
DaVita opens PI facility for kidney research
DaVita Clinical Research has opened a Phase I facility focussed on kidney research in a bid to meet a “growing demand” for renal trials.