On December 18, 2014, FDA released proposed regulations that would make prescribing information for drugs and biologics available online and prohibit distribution of paper copies as part of product packaging. FDA's stated goal is to make prescribing information widely and easily accessible to healthcare providers and consumers alike, but some consumer and provider groups are criticizing the proposed rules because they may limit access to prescribing information in communities where the Internet is not readily available. The proposed rules also go against Senate ...
Recent Updates
- States Further Legislation to Restrict Sale of Weight Loss, Muscle Building Products to Minors
- 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