Revising FDA: Fees, Mail Delays, Openness, Efficiency (Medical Device Link)
The time for revising FDA has arrived. Through the vehicle of user-fee reauthorization, the remaking of this agency is likely to be the most extensive in its history. Tied onto this reauthorization is a list of fixes that reach far beyond merely charging industry for product approvals.

Zydus Cadila gets US FDA marketing nod for 3 drugs (PharmaBiz)
Zydus Cadila has received three product approvals from the US FDA in quick succession. The group has received approvals to market benzonatate tablets 100 and 200 mg, naproxen tablets and tentative approval for amlodipine besylate tablets 2.5, 5 and 10 mg.