FDA Proposes E-Labeling Shift To “Structured Product Labeling” Format
FDA is moving toward processing electronic submissions in a "structured product labeling" format rather than the portable document format (PDF), a draft guidance on e-labeling says
You may also be interested in...
An FDA electronic labeling archive will help physicians and consumers make head-to-head comparisons between drugs, Commissioner McClellan said Dec. 9
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 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