GeriPal

JUNE 20, 2022

Staff has been working overtime with fewer resources, as programs accommodate internally displaced persons and deal with shortages of supplies, medications, and staff. Families are unable to visit their loved ones and patients suffer from limited access to care and medications.

Supply Chain 55

Supply Chain Healthcare Professional Illness Healthcare 55

FDA Law Blog

OCTOBER 12, 2022

Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA). Because many harm reduction programs don’t have a pharmacy or medical license, wholesale distributors may determine that they are ineligible to purchase prescription drugs.

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Supply Chain Individual Provider Patient-Centered 52

FDA Law Blog

JUNE 5, 2022

Mullen — On June 3, FDA announced, via email to industry, that it plans to withdraw the guidance “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised).”

Supply Chain 52

Supply Chain Medical IT 52

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. If your child has special health needs, be sure to check with their doctor about medically appropriate and safe feeding alternatives.

Supply Chain 52

Supply Chain Specialization IT DO 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). 21 U.S.C. §

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

FDA Law Blog

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Finally, as a general matter, every firm needs to make sure its supply chain stakeholders (e.g.,

Specialization 45

Specialization Supply Chain Manufacturing Medical 45

FDA Law Blog

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. API and its source and any alternative sources; associated medical devices), and expected duration of the interruption. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

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. In Section I.A,

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

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Clinic Supply Chain Clinical Practice Patient-Centered 64

FDA Law Blog

JANUARY 24, 2024

Karst — In September 2022, while the world was still in the midst of the COVID-19 epidemic and dealing with significant supply chain woes, President Biden issued an Executive Order— Executive Order 14081 —titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”

Supply Chain 69

Supply Chain Manufacturing Government Provider 69

BMJ

AUGUST 20, 2021

Increased health anxiety has been a feature of the pandemic, with fears around leaving the home, social distancing, hand hygiene, and shortages of goods and medications due to panic buying commonplace. Despite the spike in prescribing of insulins, oral antidiabetic medications were not similarly affected.

Primary Care 40

Primary Care Supply Chain General Practitioner Vaccination 40

GeriPal

SEPTEMBER 14, 2023

And we then did a bunch of work to develop medical criteria, to choose the right patients for hospital-at-home. And now, that has been expanded even further, as programs get more competent, and have better ability to keep eyes on the patient, and know what’s going on, and coordinate the logistics and supply chain to support the model.

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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.

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59