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

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).

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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. By Holly N.

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

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. protecting the clinical trial’s goal of continuing to produce valid data to support eventual regulatory decision-making).

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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

Major Barriers Persist The state plans to start by importing medications for chronic conditions like HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder for patients under the care of its state agencies before expanding the program to Medicaid patients. See 21 C.F.R. 251.5; § 251.6(c). 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. Last Thursday, the U.S. The actual policy proposals read like a wish list. LEGISLATIVE PROPOSALS.

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Manufacturing Supply Chain Patient-Centered Utilities 98