In an effort to address the challenge of increasing drug prices for patients and families, the U.S. Food and Drug Administration (“FDA”) and the U.S. Department of Health and Human Services (“HHS”) recently outlined a proposal for facilitating the importation of pharmaceuticals originally intended for foreign markets. The Safe Importation Action Plan (the “Action Plan”), jointly announced on July 31, 2019, describes two different potential pathways for importing certain drugs. The Action Plan offers only a limited overview of the proposed pathways and does not ...
As 2015 winds down, I think it is safe to say that it has been a whirlwind year in telehealth. According to the National Conference of State Legislatures (NCSL), over 200 telehealth-related bills were introduced in 42 states. The Federation of State Medical Boards (FSMB) has launched an interstate physician licensure compact that creates a new pathway to expedite physician licensure in multiple states. Twelve states (with Wisconsin being the latest) have so far enacted the licensure compact. Many states such as Colorado, Iowa, and Louisiana released regulations or policies that in ...
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Recent Updates
- Importance of Negotiating Maintenance, Repair and Replacement Obligations in Health Care Leases
- Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program
- Federal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?
- HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including Algorithms
- It’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived