Government Hospital Manufacturing Supply Chain 
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. Watering down formula to stretch it out can cause nutritional imbalances in your baby and lead to serious health problems that require hospitalization. Is that safe?
FDA Law
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.
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FDA Law
JULY 12, 2021
Two states have submitted importation plans to FDA for approval, but the rule and the certification were promptly challenged in federal court by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other interest groups. Among the Order’s mandates for DHHS are several relating to prescription drugs.
FDA Law
SEPTEMBER 13, 2021
A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.
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