FDA Law Blog

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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The Medical Futurist

JUNE 21, 2025

In 2016, The Guardian reported that a blind woman suffering from this disease was fitted with the implant labelled “bionic eye” in the UK as part of a trial at the Oxford Eye Hospital. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. That must have been truly amazing!

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FDA Law Blog

JUNE 22, 2023

He also identified “Next-Generation Home-based Testing Technologies, including new IVDs, Digital Lateral Flow Readers, and Reporting Technologies” as an opportunity to “extend care from the hospital and clinic into the home setting.” lay users). seeking treatment). HbA1c, diagnosis of a particular virus, etc.).

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Georgetown Pediatrics & Family Medicine

MAY 11, 2022

They may have samples in stock, connections to other local organizations, or ideas of other places to call, such as your local WIC clinic. Watering down formula to stretch it out can cause nutritional imbalances in your baby and lead to serious health problems that require hospitalization. Can I make my own baby formula?

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FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Other medical information.

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FDA Law Blog

MARCH 31, 2022

Last week, CMS issued Manufacturer Release 116 to put flesh on the bones of the new multiple best price option, including details about the structure of VBP arrangements and the respective responsibilities of manufacturers, states, and CMS. The manufacturer will report a best price corresponding to each GNUP. See 42 C.F.R.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study.

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GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

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FDA Law Blog

JANUARY 5, 2023

It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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FDA Law Blog

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(e) Draft Guidance III.B.2(d)

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FDA Law Blog

MARCH 31, 2024

Nevertheless, lawmakers appeared eager to pursue a legislative solution and try to force stakeholders back to the table. The FDA proposed rule elicited some strong criticism. He emphasized that FDA regulatory oversight should focus on those tests that pose the highest risk to patients.

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Annals of Family Medicine

NOVEMBER 20, 2024

Objectives: 1) Participating clinics begin to provide mifepristone for early pregnancy loss (EPL) and/or abortion care. Setting and Population Studied: The ExPAND 2022-23 cohort supported 3 clinics in the Midwest (1 FQHC, 2 community hospital clinics). times those of pre-survey respondents (95% CI 1.10-3.87).

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FDA Law Blog

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

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FDA Law Blog

OCTOBER 16, 2024

To that end, FDA approved the MSN ANDA without the modified dosing regimen and with the indication “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction.

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. HHS would then use MRAP scores in the proposed Hospital Resilient Supply Program (HRSP).

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. Remarkably, manufacturers may not dispute a CMS notification.

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FDA Law Blog

AUGUST 7, 2024

ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.” Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.

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FDA Law Blog

OCTOBER 17, 2023

This implies that if device technologies and features can produce a clinically meaningful impact for the treatment or diagnosis of a condition in certain populations, such data could support the case that the device satisfies the first designation criterion.

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GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Vincent’s Hospital in Melbourne, Australia.

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FDA Law Blog

JANUARY 18, 2024

whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. “Marijuana,” subject to the rescheduling recommendation, means all parts of the plant Cannabis sativa L., 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

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GeriPal

MARCH 2, 2023

Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. And for that reason, there was actually an enormous lawsuit, and the manufacturer was fined, now I think 20 years ago, in the millions and millions of dollars for off-label prescribing. Nisha: Thank you so much.

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GeriPal

MARCH 24, 2022

So every transition into the hospital, every transition out of the hospital. And so I think maybe it’s best just to call it care planning because I think most of the things that I do in palliative care when I’m talking to patients even in the hospital is advanced, as you’re saying. Eric: Susan. Susan: Yeah.

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Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. For providers, it is highly encouraged to submit samples from hospitalized patients to a laboratory capable of identifying H5N1 if influenza is confirmed in the inpatient setting and H5N1 is suspected.

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FDA Law Blog

MAY 21, 2024

DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614. Basis at 24; NPRM at 44,617. NPRM at 44,617. at 44,617, 44,619.

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GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. We really do not.

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FDA Law Blog

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Dr. Baron spoke to specific actions sponsors can take to improve representation of women in cardiac clinical trials.

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FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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