Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016

Consumer articles about over-the-counter and prescription drugs.

Generic Drug Facilities, Sites and Organization Lists

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults with industry and the public to create an annual list of regulatory science initiatives on generic drugs. These priorities are discussed and developed in public meetings and workshops, resulting in several awarded projects

To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint

Caraco Pharmaceutical Laboratories. Recall Enterprise System (RES) recall details