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Drug Shortages
Drug Shortages Continue to Worsen
Shortages of life-saving drugs, including cancer drugs, have been in the news in recent months. The United States House of…
California Getting into the Generic Drug Business?
Earlier this month, California’s state legislature approved a bill that would allow the state to be the first state to develop its…
Trump Signs Executive Order Regarding Medical Supply Chain
On August 6, 2020, President Donald Trump issued an executive order (EO) aimed at the medical supply chain in America. The EO,…
FDA CDRH Issues Guidance on Notifications of Medical Device Shortages
Recently, the US Food and Drug Administration (“FDA”) Center for Devices and Radiological Health (“CDRH”) published guidance…
FDA Issues Guidance on Drug Shortage Notifications
In view of potential drug supply interruptions due to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) recently…
Sanofi Doesn’t Expect Drug Shortages Related to COVID-19
One of the concerns patients have surrounding COVID-19 is the possibility of drug shortages, especially as countries around the…
FDA Releases Report on Drug Shortages and Encourages Manufacturer Quality…
The Food and Drug Administration (“FDA”) Drug Shortages Task Force recently released a report, entitled Drug Shortages: Root…
FDA Holds Meeting to Identify Cause of Drug Shortages
The US Food and Drug Administration (FDA) is working to update its approach to drug shortages after several high-profile…
FDA Creating New Drug Shortage Task Force
The United States Food and Drug Administration (FDA) recently announced the creation of a new drug shortage task force, led by…
FDA Considering Removing Regulatory Obstacles to Generic Competition
Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage…