GPhA policy (correction)
The Generic Pharmaceutical Association supports the goal of the Food and Drug Import Safety Act, but the association does not endorse the use of import fees to improve FDA's foreign inspection program. A previous article indicated that GPhA supports the proposed legislation (1"The Pink Sheet" Aug. 13, 2007, p. 21)...
You may also be interested in...
Inspection Of Rx Imports Would Climb Under Bill Setting $300 Mil. In User Fees
Drug import fees totaling $300 million each in fiscal years 2008 through 2012 would be authorized by a food and drug import safety bill being developed by House Energy and Commerce Committee Chairman John Dingell, D-Mich
US FDA Complete Response Letter Rates Vary With Sponsor Size
Pink Sheet infographic illustrates benefits of big pharma’s resources and experience.
Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?
Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?