FDA CLEARS 53 NMEs IN 1996 -- AVERAGE APPROVAL TIME IS 20.5; NEUROPHARM DRUGS APPEAR READY FOR 1997 CLEARANCE: THREE PARKINSON's THERAPIES POISED FOR APPROVAL
Executive Summary
Three Parkinson's disease therapies appear on track for approval in 1997, continuing the prominence of central nervous system drugs among products reaching the commercial stage.
You may also be interested in...
US FDA Blows Past Novel Approvals Record On Way To Unprecedented Year For New Drugs
Roche’s Xofluza brings novel approval count for CDER to 47, topping 2017's record – and FDA still has at least 14 novel agents under review with 2018 goal dates.
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