Posts tagged House of Representatives.
Blogs
5 minute read
The Food and Drug Administration (FDA) issued a draft guidance (Draft Guidance) on July 11, 2016 that allows some generic drug manufacturers holding an Abbreviated New Drug Application (ANDA) to update the label of the drug they manufacture with new safety information. The Draft Guidance provides new clarifications and recommendations to generic drug manufacturers seeking to update a generic label after withdrawal by the name brand manufacturer of the reference listed drug (RLD) (a "Withdrawn RLD"). The Draft Guidance explains how a generic manufacturer may submit an updated ...
Blog Editors
Recent Updates
- Proposed Modernization of the HIPAA Security Rules
- In Confirmation Hearings, AG Nominee Pledges to Defend the Constitutionality of the False Claims Act
- A Primer on Executive Orders and a Preview of the Road Ahead
- At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration . . .)
- Massachusetts District Court Applies “But-For Causation” Standard, Dismisses AKS-Based FCA Case After Evaluating Facts and Circumstances of Independent Contractor Arrangements