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FDA launches a Drug Supply Chain Security Portal as part of the CDER Next Gen Portal.[ Price : $8.95]
FDA denies for reasons of safety a 2017 petition seeking approval to submit an ANDA for a generic form of Bristol-Myers Squibbs El...[ Price : $8.95]
FDA posts a 10-item Form FDA-483 related to an inspection last month at SCA Pharmaceuticals Windsor, CT outsourcing facility.[ Price : $8.95]
FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.[ Price : $8.95]
FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (tr...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.