FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health.

Manufacturing 59

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FDA Law

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. is it the lab itself, the healthcare provider, or the patient?).

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FDA Law

AUGUST 27, 2023

The Guidance specifically states that it is issuing the Guidance – applicable to trading partners including manufacturers, distributors, dispensers, and repackagers – to address industry “readiness” to comply with the DSCSA’s provisions. Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. & A healthy 46-year-old patient who has lived for over 30 years with missing bilateral maxillary incisors desired a fixed solution to his problem.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law

OCTOBER 10, 2023

Performance data should be customized to the indications for use, including the specific intended patient population (adult vs. pediatric), disease state, conditions of use, and the target anatomical location. In cases where devices are expected to be frequently replaced, testing should be guided by the aggregate patient exposure.

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FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(d)

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Physician's Practice

JUNE 9, 2025

68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

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Management Telemedicine Insurance Patients 52

FDA Law

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc.

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GeriPal

MAY 5, 2022

And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia. And so often we get consulted by teams that say, “I have this older patient and they’re pretty isolated and I think they have dementia. It’s amazing.

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IT Screening Hospital Clinic 102

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Manufacturing Provider Physicals Electronics 64

FDA Law

MAY 15, 2025

Livornese Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Claud & Deborah L.

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Manufacturing Vaccination Illness IT 59

FDA Law

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. Just like it was over a decade ago in Pliva v.

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Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. And that’s a good thing to share with an older patient or client that making decisions about your activity.

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Healthcare IT Education Community 128

FDA Law

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. Perhaps anticipating a less than favorable outcome, DOJ counsel several times asked to be allowed to submit a brief on the question of the remedy in the event of an adverse ruling.

Patient-Centered 102

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FDA Law

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications. Maisel also discussed disposition of already distributed devices.

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Manufacturing Medical Patient-Centered Provider 59

FDA Law

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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