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 ...
We recently outlined key provisions of the Environmental Protection Agency’s (EPA’s) Final Rule modifying the standards governing industry management of hazardous waste pharmaceuticals, which become effective August 21, 2019. Client Alert
Impacted industries must immediately comply with the nationwide ban on the sewering of hazardous waste pharmaceuticals as of the August 21st effective date. The ban applies to a wide range of stakeholders, including, but not limited to reverse distributors, pharmacies, hospitals, and wholesalers.
Additional regulatory changes ...
Blog Editors
Recent Updates
- Supreme Court of Ohio Decides on a Peer-Review Privilege Issue in Stull v. Summa
- Unpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA
- Importance of Negotiating the Letter of Intent for Health Care Leases
- Importance of Negotiating Default Provisions in Health Care Leases
- Podcast: Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care