FDA mixed messages create QbD confusion; consultant
Variable understanding of QbD among US FDA reviewers is leading to mixed messages and confusion, a consultant said.
Archives for July 25, 2012
Regulatory pressures on microbial drug production means big wins for Cherwell Laboratories
Cherwell Laboratories has more than doubled the size of its Bicester, UK, plant that manufactures prepared media for microbial production after a boom in demand for its goods.
Teva makes first Indian forray with help of P&G
Teva Pharmaceuticals is set to build its first Indian production plant after finalising a pact with healthcare giant Procter & Gamble (P&G), according to local authorities.
UPDATE
Covance's flagging early phase biz puts downer on net profits in Q2
Covance has reported a net loss of $12.7m in this year’s Q2 as what it says is the result of facility closures and restructuring costs, particularly for its early phase development section.
PCORI says Pharmas may bias trials
The US Patient-Centered Outcomes Research Institute (PCORI) has suggested the pharmaceutical industry is introducing bias into clinical trials through selective use of inclusion/exclusion criteria and comparators.
News from the FDA, Cipla and Array – People on the move
in-PharmaTechnologist.com presents its weekly round-up of the latest new hires in the pharmaceutical industry, including news from the FDA, Cipla and Array.