In Vitro Data Removal From Labeling Would Hinder Marketing, Alcon Says
Removing in vitro data from anti-infective labeling would limit a company's ability to differentiate its products, Alcon said in comments on FDA's proposed labeling rule.
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Sponsors would have one year to remove in vitro data that has not been clinically validated from labeling, under proposed FDA guidelines for simplified prescription drug labeling.
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