BakerHostetler | USA | 13 Aug 2015
Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015…
BakerHostetler | USA | 7 May 2015
Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved…
BakerHostetler | USA | 12 Mar 2015
The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections…
BakerHostetler | USA | 26 Feb 2015
Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug…
BakerHostetler | USA | 26 Sep 2014
The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional…
BakerHostetler | USA | 25 Sep 2014
Last week, the Food and Drug Administration (FDA) announced that it has published a list of licensed biological products and interchangeable…
BakerHostetler | USA | 22 Sep 2014
At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration…