The generic drug industry — and by extension, patients across the United States — is being adversely impacted by what some are calling branded drug makers’ abuse of risk evaluation and mitigation strategies, or REMS.
Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.
Americans aspire to be healthier by making better food choices, but admit that the saying is a lot easier than the doing, according to a new white paper titled "Health and Wellness in America" released by Nielsen and the Natural Marketing Institute last week.
The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.
Amneal Pharmaceuticals announced four new additions to its portfolio of generic drugs, which represent multiple therapeutic categories and account for $900 million annually in U.S. sales, the company said, citing data from IMS Health.
The European Union is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralized procedure in real time with collaborating regulatory agencies outside the EU.