On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
8/13/2021
/ Biotechnology ,
Drug Approvals ,
Drug Compounding ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Genus ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Public Comment
FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more
2/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Comment Period ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Orange Book ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product Packaging ,
Regulatory Agenda