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. syringes), to any individual without a patient-specific prescription.

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FDA Law Blog

AUGUST 27, 2023

FDA intends the Guidance to provide “clarity and flexibility” to trading partners to “help ensure continued patient access to prescription drugs as the supply chain transitions to the interoperable, electronic product tracing at the package level under the DSCSA” while supporting “continued availability of products to patients.”

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Supply Chain Electronics Manufacturing Provider 52

FDA Law Blog

FEBRUARY 4, 2022

Richardson — FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). The Rule, if enacted in its current form, will have sweeping implications throughout the supply chain, but particularly for WDDs and 3PLs. By Karla L.

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Supply Chain Manufacturing Provider IT 40

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.

Management 45

Management Manufacturing Supply Chain Provider 45

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.

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Supply Chain Manufacturing Government Hospital 59

FDA Law Blog

OCTOBER 11, 2023

In general, both of these guidances provide recommendations for sponsors to consider and analyze when a disaster (e.g., For example, a disaster or public health emergency may lead to clinical trial disruptions via population quarantines, travel restrictions, various interruptions to the supply chain, and other logistical issues.

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Clinic Supply Chain Clinical Practice Patient-Centered 64

FDA Law Blog

FEBRUARY 16, 2023

sales of naloxone from a wholesale distributor to a harm reduction program) from certain requirements under the Drug Supply Chain Security Act. mistakenly administered to a patient who is not experiencing an overdose), and (3) an Rx-to-OTC switch for NNS will save lives.

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Supply Chain Healthcare Professional Community IT 64

BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2021-001143 The COVID-19 pandemic has resulted in profound changes in patient and prescriber behaviour. In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions.

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Primary Care Supply Chain General Practitioner Vaccination 40

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

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Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c).

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Supply Chain Manufacturing Chronic Condition Government 59

FDA Law Blog

SEPTEMBER 13, 2021

Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs. The Plan supports legislative action to control total drug costs and patient out-of-pocket (“OOP”) costs for Medicare Part D beneficiaries. Increase Transparency and Strengthen Supply Chain and Research Capacity. ADMINISTRATIVE ACTIONS.

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Manufacturing Supply Chain Patient-Centered Utilities 98