US FDA’s Hamburg offers few details on trip to India
In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.
Archives for February 25, 2014
FMC asks CBC to help it become bigger in Japan
FMC has hired Connell Brothers (CBC) to distribute its drug excipients in Japan, citing the move as a key step to building its business in the country.
FDA re-evaluates 5-year NCE exclusivity to incentivize development of fixed-combo products
The US FDA on Monday announced in a draft guidance that it’s revising its historical interpretation of the 5-year NCE exclusivity provisions to further incentivize the development of certain fixed-combination products.
UPDATE-2
Ranbaxy voluntarily halts production at its Indian API plants
Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.
PPD deals to increase presence in expanding German trials sector
CRO Pharmaceutical Product Development (PPD) and the Charité – Universitätsmedizin hospital in Berlin are collaborating to increase the volume of clinical trials conducted in Germany.
Drug developers turn to recreational users for addiction expertise
A history of recreational drug use normally stops someone taking part in a trial, but growing US FDA pressure for data on a drug’s abuse potential has prompted CROs to start recruiting users says INC Research.