ANDA Reviews Reorganized To Speed Approval; Dissolution Now First In Line
Executive Summary
The Division of Bioequivalence in FDA's Office of Generic Drugs has begun conducting dissolution tests earlier in the ANDA review process to speed approvals
You may also be interested in...
ANDA Approvals Jump 44%; FDA Works On Roadblocks As Review Times Drop
FDA's Office of Generic Drugs approved 380 abbreviated new drug applications in 2004, a 44% increase over the previous year
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011