Adding Warnings To Labeling Will Be More Complicated Under Final Rule
Executive Summary
Labeling changes, especially the addition of warnings, could be complicated under FDA's new physician labeling because of the requirement to obtain a prior approval supplement (PAS) before revisions to the Highlights section can be finalized
You may also be interested in...
Labeling “Highlights” To Depend On Data In Relation To Clinical Setting
Information to be included in the new Highlights of Prescribing Information section of professional labeling will be determined by the clinical setting in which the drug is used, FDA said
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