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FDA publishes a draft guidance with recommendations on how ANDA applicants can demonstrate sameness between the active ingredient ...[ Price : $8.95]
FDA raises uncertainties with Verus request for Covid-19 treatment emergency use authorization for its repurposed investigational ...[ Price : $8.95]
CDERs Office of New Drugs denies an Omeros appeal of complete response letter on its BLA for narsoplimab as a treatment for hemato...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Angel Medical Systems Angel...[ Price : $8.95]
The Combination Products Coalition says its members have several concerns with recent FDA requests for validation of product inter...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Kyowa Kirins Nourianz (istr...[ Price : $8.95]
Two Wiley Rein attorneys caution medical device manufacturers to start preparing their transition plans and marketing applications...[ Price : $8.95]
FDA appears to be raising the bar for sponsors seeking accelerated approval by requesting that they be well underway with their Ph...