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. Author: Ishani Majmudar Medical waste is rising tremendously each year, and its implications are not slight. 4 Changing to multiuse bottles will be challenging.

Medical 52

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. Of course, CDER is a massive organization and OC doesn’t do its work alone. Clinical Trials.

Supply Chain 59

Supply Chain Clinic IT Provider 59

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. Check smaller stores and drug stores, which may not be out of supply when the bigger stores are. What if baby formula is out of stock everywhere I look?

Supply Chain 52

Supply Chain Specialization IT DO 52

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.

Supply Chain 52

Supply Chain Provider Government Complication 52

FDA Law Blog

JULY 24, 2024

The American Conference Institute (“ACI”) is holding its 10th Anniversary Paragraph IV Disputes Master Symposium from October 15-16, 2024, at the Hyatt Regency McCormick Place in Chicago, Illinois. s Kurt R.

Supply Chain 52

Supply Chain Clinic IT 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.

Healthcare 130

Healthcare Family Physician Management Individual 130

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.

Supply Chain 52

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

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? Does the stand down of FCPA enforcement mean that its okay to bribe foreign officials now? A one-size-fits all approach to communication of important principles is therefore less likely to be successful.

Supply Chain 66

Supply Chain Management IT Manufacturing 66

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.

Supply Chain 52

Supply Chain Manufacturing IT 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). Proposed Rule at 30.

Supply Chain 40

Supply Chain Manufacturing Provider IT 40

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. By Allyson B.

Supply Chain 52

Supply Chain Medical IT 52

FDA Law Blog

MARCH 4, 2024

Given the disruptions in supply that have continued to occur even beyond the end of the pandemic crisis, it is not surprising that FDA has issued a draft guidance on this subject. Early notification can play a role in decreasing the impact and duration of such supply disruptions and product shortages.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

FDA Law Blog

MARCH 27, 2023

Finally, as a general matter, every firm needs to make sure its supply chain stakeholders (e.g., (Emphasis added.) Planning Now is a Good Idea If a firm needs to remove NHRIC and NDC legacy identifiers or currently relies on UDI-A160001 and UDI-A160002 , it would be wise to plan for the transition. It is not far off!

Specialization 45

Specialization Supply Chain Manufacturing Medical 45

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

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.

Supply Chain 59

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.

Supply Chain 52

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

Clinic 64

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. All 19 members of the joint Advisory Committee agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a nonprescription opioid overdose reversal agent.”

Supply Chain 64

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.”

Supply Chain 69

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.

Primary Care 40

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.

Supply Chain 75

Supply Chain Manufacturing Engineering Consulting 75

GeriPal

SEPTEMBER 14, 2023

In addition to discussing these outcomes, we also discuss: The history of the hospital-at-home movement. The practicalities of how it works including who are good candidates, where does it start (the ED?), what happens at home, do you need a caregiver, what happens if they need something like imaging? How is it financed and what comes next?

Hospital 115

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.”

Supply Chain 52

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. See 21 C.F.R.

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59

FDA Law Blog

SEPTEMBER 13, 2021

Kirschenbaum — Despite vigorous criticism of high drug prices from the public and politicians in both parties, drug companies have largely dodged bullets on drug pricing and payment reform. Last Thursday, the U.S. The actual policy proposals read like a wish list. Below, we summarize the key proposals of the HHS plan. LEGISLATIVE PROPOSALS.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98