Protocols and planning key to avoiding warning letters; FDA
Better designed protocols and early identification of risks can improve trial quality and help avoid warning letters, said the FDA.
Archives for July 4, 2011
Europe approves Merck Serono prefilled pen injectors
Merck Serono has received European approval for prefilled pen injectors designed to increase compliance during fertility treatment.
Update
Second partnership for Fujifilm and Mitsubishi
Fujifilm and Mitsubishi have embarked on a joint business venture in the contract manufacturing for biopharmaceuticals.
AAI gets FDA OK for analytical lab
AAIPharma Services says its analytical lab in Durham, North Carolina has passed its fourth consecutive US FDA audit with no 483 observations.
Theorem CR talks about life after spin out at DIA 2011
Rebranded CRO Theorem Clinical Research talks about life as an independent organisation and the current vogue for private equity investments.
Angel providing GMP stem cell production to ReNeuron
ReNeuron has inked a new deal with Angel Biotechnology to outsource stem cell GMP production services to the CMO.
Strides receives OK from EMA
Onco Therapies Limited (OTL), a division of Aglia, a wholly owned subsidiary of Strides Arcolab Limited, has been given the go ahead from Europe for its Oral Dosage Oncology facility.
EMA OK for second Shire Replagal plant
Shire has received European Medicines Agency (EMA) approval for a new US plant, doubling purification capacity for its Fabry disease drug Replagal.