The Medical Futurist
JUNE 17, 2025
Artificial intelligence Already, dentists employ software to get insights into clinical decision-making, but AI is changing the face of dentistry, just like it is in many other fields. But AR also found a home in dentistry for both educational and clinical purposes.
FDA Law
JULY 5, 2023
Under section 503B, drugs compounded by an FDA-registered outsourcing facility under the supervision of a licensed pharmacist can qualify for exemptions from FDA approval, labeling with adequate directions for use, and certain drug supply chain security requirements, subject to specific conditions. See 21 U.S.C. Section II at 2.
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My Green Doctor
MAY 3, 2025
Dilating and anesthetic eye drops are used routinely to treat patients in most ophthalmology clinics. The standard of care worldwide in clinics is to use multidose eyedrop bottles — meaning there is enough medicine one bottle to treat many patients. The product manufacturers and vendors will need to be active partners as well.
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. They may have samples in stock, connections to other local organizations, or ideas of other places to call, such as your local WIC clinic. Can I make my own baby formula?
FDA Law
OCTOBER 12, 2022
Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA). It may not be clear to supply chain stakeholders which entities may be considered “harm reduction programs” for the purposes of this Guidance.
FDA Law
MARCH 1, 2023
FDA published two Federal Register Notices in October 2020 to recruit domestic drug product manufacturers of finished dosage forms and foreign manufacturers of active pharmaceutical ingredients to participate in the QMM Pilot Programs. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).
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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