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 ...
Recent Updates
- Comment Period Closes on California OHCA’s Proposed Emergency Regulations Expanding Private Equity, Hedge Fund, and MSO Reporting in Health Care Transactions
- DOJ Revises Justice Manual on Non-Binding Guidance and Qui Tam Dismissals: Practical Considerations
- Additional SBA Crackdown on Pandemic-Era Fraud Leads to Program and Loan Suspensions, Possible FCA Enforcement
- Federal Regulatory Views on Cybersecurity and AI Amidst a Growing Threat Landscape
- Remote Monitoring Services Under the 2027 PFS Proposed Rule: Epstein Becker Green Submits Comments to CMS