FDA Law Blog
JUNE 30, 2022
The FDA’s proposed licensing rule would implement a long-awaited provision of the 2013 Drug Supply Chain Security Act (“DSCSA”) that establishes the requirement for national license standards for WDDs and 3PLs. 6,708 (Feb. 1) In general.–Beginning 2) State regulation of third-party logistics providers.
California Academy of Family Physicians (CAFP)
MAY 14, 2025
Key Health Care Budget Proposals: Proposed Medi-Cal Cuts and Enrollment Changes Medi-Cal, California’s Medicaid program, is typically funded through a partnership between the state and the federal government. To fill that gap, California has chosen to use state-only funds to provide certain Medi-Cal benefits to undocumented Californians.
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Georgetown Pediatrics & Family Medicine
MAY 11, 2022
Current shortages have been largely caused by supply chain issues and the recent recall of several baby formula products over concerns about contamination. I heard the government will be importing baby formula from other countries. To find an accredited milk bank, check here. Is that safe?
FDA Law Blog
FEBRUARY 26, 2025
How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands? With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance word.
FDA Law Blog
MARCH 1, 2023
In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.
FDA Law Blog
APRIL 8, 2024
Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. Section I.C
FDA Law Blog
JANUARY 24, 2024
Karst — In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order— Executive Order 14081 —titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”
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