The Medical Futurist
JUNE 17, 2025
Just like in the case of other medical specialties , disruptive innovations will have a huge impact on how dentistry will be practiced and how patients will take care of themselves in the future. For patients, it promises more accurate care and better outcomes. How about having a teledentist consultation?
FDA Law Blog
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
Innovative surgeries, novel pharmaceuticals, and state of the art technology are just a few of the driving forces that have aided the delivery of exceptional care to patients across all specialties. Dilating and anesthetic eye drops are used routinely to treat patients in most ophthalmology clinics. 3 “Each U.S.
FDA Law Blog
AUGUST 27, 2023
The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.
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.,
FDA Law Blog
FEBRUARY 4, 2022
The Drug Supply Chain Security Act (“DSCSA”), enacted back in November 2013, directed FDA to create national licensure standards for wholesale distributors and 3PLs within two years of its enactment (i.e., The comment period for the Proposed Rule will remain open until June 4, 2022 (120 days after publication).
FDA Law Blog
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).
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