Chart: New Molecular Entities Approved In The First Half Of 2010
Executive Summary
New Molecular Entities Approved In The First Half Of 2010
You may also be interested in...
FDA's NME Approval Rebound At Risk: Drought Of Novel Products In Line For Action In Remainder Of 2010 Could Depress Upward Trend From First Half
Almost one-third fewer novel product applications are on FDA's user fee calendar for the second half of 2010 as compared to the docket at the same point in 2009, a dearth that could imperil the slow but steady improvement in annual new molecular entity and novel biologic approvals after the nadirs reached earlier in the decade
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
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials