My Green Doctor

MAY 3, 2025

Single use has become the custom for most clinicians and managers, just as disposable products have become prevalent across the medical supply chain. Additionally, the post-operative infection rates reported at Aravind were found to be lower than the rates in the United States, which employs a single-dose policy.

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Medical Supply Chain Hospital Healthcare 52

FDA Law Blog

JANUARY 22, 2024

Drug Supply Chain. Recalls, warning letters to online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year.

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Supply Chain Clinic IT Provider 59

FDA Law Blog

JUNE 30, 2022

The FDA’s proposed licensing rule would implement a long-awaited provision of the 2013 Drug Supply Chain Security Act (“DSCSA”) that establishes the requirement for national license standards for WDDs and 3PLs. 6,708 (Feb. 1) In general.–Beginning 2) State regulation of third-party logistics providers.

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Supply Chain Provider Government Complication 52

GeriPal

JUNE 20, 2022

The All-Ukrainian Associate of Palliative and Hospice Care was founded in 2011 and is currently working to provide support and direct supplies to hospices and palliative care wards in the country.

Supply Chain 55

Supply Chain Healthcare Professional Illness Healthcare 55

FDA Law Blog

JULY 24, 2024

s Kurt R.

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Supply Chain Clinic IT 52

FDA Law Blog

JANUARY 11, 2024

Boasting a highly skilled workforce, state-of-the-art facilities, and a supportive business environment, it’s no surprise that Puerto Rico has become a hub for industry pioneers in biopharma, research, supply chain management and technology. HPM is a co-sponsor of the event. The event is hosted by by Porzio, Bromberg & Newman.

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Supply Chain Management 59

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). It may not be clear to supply chain stakeholders which entities may be considered “harm reduction programs” for the purposes of this Guidance.

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Supply Chain Individual Provider Patient-Centered 52

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.”

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

California Academy of Family Physicians (CAFP)

MAY 14, 2025

This expansion would enable the state to: Secure an affordable and stable supply of both generic and brand-name drugs, Respond effectively to supply chain disruptions or politically motivated access restrictions, Protect access to medications such as mifepristone and other drugs threatened in other states.

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Healthcare Family Physician Management Individual 130

FDA Law Blog

JULY 18, 2023

The report reiterated a commitment to maintain the supply chain and provides more context about how OPQ—and FDA, more generally—are approaching quality and enforcement as we continue to hurtle past the COVID-19 public health emergency (PHE). 2022 marked the fifth straight year that FDA labs found an increasing level of noncompliance.

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Supply Chain Manufacturing IT Provider 52

The Medical Futurist

MAY 18, 2025

Robots in the supply chain Medical robots can not only undertake monotonous and repetitive tasks but also those that are potentially dangerous for humans – such as moving heavy boxes or testing chemical protection clothing.

Healthcare 64

Healthcare Hospital Medical Patient-Centered 64

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

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. From the American Academy of Pediatrics : Updated 5/19: Since the outbreak of COVID-19 , there have been significant shortages of infant formulas in stores.

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Supply Chain Specialization IT DO 52

FDA Law Blog

JUNE 5, 2022

Questions regarding biocompatibility and other tests that are typically performed by third-party laboratories or that require production units that may be constrained by on-going supply chain issues, are not uncommon in hold letters.

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Supply Chain Medical IT 52

FDA Law Blog

SEPTEMBER 16, 2024

“Innovative manufacturing” is a somewhat ill-defined term, but the agency uses it to refer to any novel manufacturing that can increase product development speed, bolster supply chains, or prevent drug shortages.

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Manufacturing IT Supply Chain Provider 59

FDA Law Blog

FEBRUARY 26, 2025

How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands? Will there be a heightened appetite for mergers and acquisitions in the space? Does the stand down of FCPA enforcement mean that its okay to bribe foreign officials now?

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Supply Chain Management IT Manufacturing 66

FDA Law Blog

MARCH 27, 2023

Finally, as a general matter, every firm needs to make sure its supply chain stakeholders (e.g., retail stores, pharmacies, and payors) are ready for the UDI transition by September 24, 2023.

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Specialization Supply Chain Manufacturing Medical 45

FDA Law Blog

MARCH 4, 2024

blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA. Others involved in the drug supply chain, such as third-party API manufacturers and suppliers, are not required to submit such notifications.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

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.

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Management Manufacturing Supply Chain Provider 45

FDA Law Blog

JUNE 3, 2021

Schlanger — While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. See our previous coverage of such state laws here , here and here.)

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law Blog

DECEMBER 8, 2021

Moore — Nothing says “happy holidays” quite like the issuance of Federal Trade Commission (FTC) orders – essentially, subpoenas – to large retailers , wholesalers and suppliers of food, cosmetics, personal care and OTC products, among other things, during the supply chain’s busiest time of the year. Amazon.com, Inc., Kroger Co.,

Supply Chain 52

Supply Chain Transportation IT Provider 52

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. Section I.C

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Supply Chain Manufacturing Government Hospital 59

FDA Law Blog

NOVEMBER 22, 2022

But as noted above, identifying points in the food supply chain, the source of the product, and where contamination may have occurred can be a long and difficult process. What information firms must maintain and share under the rule depends on the type of activities they perform in the supply chain with respect to an FTL food.

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Supply Chain Illness Family Families 52

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. In general, both of these guidances provide recommendations for sponsors to consider and analyze when a disaster (e.g.,

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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. We previously blogged on FDA’s September 2022 guidance exempting and excluding specific naloxone transactions (e.g.,

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Supply Chain Healthcare Professional Community IT 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.”

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Supply Chain Manufacturing Government Provider 69

BMJ

AUGUST 20, 2021

With prescribing and dispensing of some medications increasing as much as 50% above forecast levels during the early months of the pandemic, results from such databases may have additional implications for planning of pharmaceutical supply chains, as well as for individual prescribers.

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Primary Care Supply Chain General Practitioner Vaccination 40

FDA Law Blog

SEPTEMBER 16, 2022

The Executive Order was spurred in part by the COVID-19 pandemic, but it points out that biotechnology and biomanufacturing—defined as use of biological systems to develop products, tools, and processes at commercial scale—has other uses outside of human health, including securing supply chains and growing the American economy.

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Supply Chain Manufacturing Engineering Consulting 75

GeriPal

SEPTEMBER 14, 2023

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. Just one last comment there. You are delivering care in someone’s home environment.

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Hospital Patient-Centered Supply Chain IT 115

FDA Law Blog

JULY 12, 2021

The Secretary of Health and Human Services is directed to submit to the White House, by August 23, a plan to “combat excessive pricing of prescription drugs and enhance domestic pharmaceutical supply chains, to reduce pries paid by the Federal Government for such drugs, and to address the recurrent problem of price gouging.”

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Supply Chain Government Insurance Manufacturing 52

FDA Law Blog

JANUARY 9, 2024

If FDA grants Florida’s pre-import request for these drugs, Florida will be required to ensure supply chain integrity, monitor and submit adverse event reports, comply with drug recall procedures, and send quarterly reports to the FDA about the imported drug, cost savings, and potential safety or quality issues.

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Supply Chain Manufacturing Chronic Condition Government 59

FDA Law Blog

SEPTEMBER 13, 2021

Increase Transparency and Strengthen Supply Chain and Research Capacity. Other legislative proposals included improving supply chain transparency. ADMINISTRATIVE ACTIONS.

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Manufacturing Supply Chain Patient-Centered Utilities 98