FDA Law Blog
MARCH 4, 2024
Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.
My Green Doctor
MAY 3, 2025
Single use has become the custom for most clinicians and managers, just as disposable products have become prevalent across the medical supply chain. operating rooms is regulated by the individual states; changing to multi-dose eyedrops will require administrative and legislative advocacy by eye specialists in every state and country.
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FDA Law Blog
OCTOBER 12, 2022
Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,
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. Check smaller stores and drug stores, which may not be out of supply when the bigger stores are. Always mix formula as directed by the manufacturer.
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.
FDA Law Blog
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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