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

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. The study represents the most robust attempt at understanding the performance of serial use of rapid antigen tests for SARS-CoV-2 detection among asymptomatic individuals in the U.S. That could happen again.

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Individual Clinic Healthcare Provider 97

My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.

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Healthcare Healthcare Professional Consulting Management 52

Imperial Center Family Medicine

JUNE 2, 2025

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Multiple clinical studies verify that humans harboring elevated proportions of cholesterol-to-coprostanol converting bacteria tend to exhibit lower blood cholesterol levels and decreased risk for heart disease over time.

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Family Medicine DO Screening Specialization 52

FDA Law

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

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Manufacturing Provider Consulting IT 64

Georgetown Pediatrics & Family Medicine

MAY 11, 2022

Purchase from well-recognized distributors, grocers, and pharmacies rather than individually sold or auction sites. They may have samples in stock, connections to other local organizations, or ideas of other places to call, such as your local WIC clinic. If you can afford it, buy formula online until store shortages ease.

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Supply Chain Specialization IT Family Medicine 52

FDA Law

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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Patients Clinic Medical Patient-Centered 52

FDA Law

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.” By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B.

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FDA Law

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Avdel amicus brief).

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GeriPal

JUNE 20, 2024

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. On our last podcast about urinary incontinence the song request was, “Let it go.” I do like that one.

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IT Patient-Centered Patients Clinic 120

FDA Law

OCTOBER 6, 2022

Lewis, Senior Regulatory Device & Biologics Expert — On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. vector manufacturing for a transgene vector).

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FDA Law

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

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Telehealth Patients Manufacturing Transportation 72

FDA Law

SEPTEMBER 27, 2023

The issues appropriate for an INTERACT meeting typically relate to IND requirements, such as questions about IND-enabling studies, complex manufacturing technologies or processes, development of innovative devices used with a drug or biologic, or the use of New Approach Methodologies (methods to be used in place of traditional animal testing).

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IT Manufacturing Provider Clinic 64

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? We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. I’m guessing not. How to screen for hearing loss. Transcript.

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IT Screening Hospital Clinic 102

FDA Law

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.

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Clinic Medical Provider Patients 52

FDA Law

DECEMBER 12, 2023

In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis. (Apologies to our readers—word play is FDA Law Blog’s catnip.) RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats. Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0;

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Utilities Manufacturing Provider Individual 59

FDA Law

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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FDA Law

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It is focused on excimer lasers with premarket application (PMA) approval for LASIK in product code LZS. This proposal is not, however, simply advice for preparation of an application for a new device. Public Comments.

Manufacturing 52

Manufacturing Provider Patients Medical 52

FDA Law

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law

JANUARY 5, 2025

In either case, if the consumer wrongly enters their information, e.g., and as a result obtains a drug that had they entered the information correctly, they would not have received, does that make the drug misbranded and the drug manufacturer responsible for distributing a misbranded drug? 105288 (Dec.

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Provider Healthcare Individual Manufacturing 59

FDA Law

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

CDOCS

JUNE 30, 2021

Furthermore, upon clinical examination and evaluation of radiographs, a diagnosis of recurrent decay was established on teeth #s 6 through 11.</span></p> </span></p> <p><span style="font-size:14px;">[image:Picture1.jpg]</span><br

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Family Families Patients Manufacturing 40

FDA Law

SEPTEMBER 20, 2021

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability).

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Specialization Clinic Provider IT 40

FDA Law

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). 2 infection. A follow up laboratory?run run molecular diagnostic (RT?PCR)

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Screening Manufacturing Healthcare IT 98

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.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

OCTOBER 16, 2024

Left ventricular ejection fraction (LVEF) is a variable measure, so use clinical judgment in deciding whom to treat.” While denying a Citizen Petition from Novartis asking FDA to refuse to approve any ANDA that omits the new dosing regimen or changes the indication, FDA approved MSN’s ANDA on July 24, 2024.

Manufacturing 98

Manufacturing Patients IT Hospital 98

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. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

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Illness IT Patient-Centered Patients 107

FDA Law

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however. animal, viral, bacterial) DNA and RNA sequences.

Manufacturing 64

Manufacturing Clinic IT Vaccination 64

FDA Law

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. Other Updates With respect to the first part of the first criterion (i.e.,

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Medical Diagnosis Healthcare Clinic 53

FDA Law

JANUARY 8, 2023

The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. We discuss the statute’s major provisions summarized below. Federal Research. Specific steps the agency will take to restore an adequate, uninterrupted supply. Application Process.

Medical 64

Medical Manufacturing Electronics Provider 64

FDA Law

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. By Larry K. 29, 2023). Letter to U.S. 21 U.S.C. § 812(b)(1).

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

MARCH 24, 2022

All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics. We can work it out! Links to a few couple items mentioned on the podcast: Objectives for Advance Care Planning.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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Manufacturing Vaccination Government Diagnosis 59