Taxol Case Could Block FDA, Courts From Reviewing Patent Listings
American BioScience's case against Bristol may set a precedent preventing FDA and court review of "Orange Book" listings.
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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