On May 19th, the FDA again postponed publication of the Final Rule entitled, "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" to April 2017 (the "Final Rule"). On May 19th, the House of Representatives Committee on Appropriations approved the 2017 Agriculture Appropriations bill, which includes provisions within Section 747 expressly defunding any efforts by the FDA to enact the rule. The Notice of Proposed Rule-Making ("NPRM") was originally published in November 2013 to provide generic drug and biologics manufacturers ...
Blog Editors
Recent Updates
- False Claims Act Exposure in Focus: President Trump Signs Executive Order Targeting DEI Programs
- 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 . . .)