FDA Law

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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Medical Clinic Patients IT 111

FDA Law

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law

JANUARY 15, 2024

If you made it through the first 2 pages of the opinion, this Court’s answer is clear: FDA flagrantly violated the APA in denying those flavored e-cigarette applications due to the Agency’s utter failure to provide comprehensible instructions and consistent policies. FDA also directed manufacturers to produce detailed marketing plans.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

Clinic 98

Clinic Provider IT Patients 98

FDA Law

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e.,

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

Diagnosis 59

Diagnosis Clinic Provider IT 59

FDA Law

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. Comments may be submitted until February 7, 2022.

Medical 98

Medical Manufacturing Healthcare Government 98

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. The Journal of Clinical Psychiatry. 2018 May/Jun;79(3):17r11506. As Nicholas et al. Pediatric Emergency Care.

Family 77

Family Families Patient-Centered Physicals 77

FDA Law

DECEMBER 16, 2024

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review. Fiscal Year 2023 showed similar performance.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. But that is only the beginning.

Provider 75

Provider IT Engineering Medical 75

FDA Law

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

IT 52

IT Clinic Provider Medical 52

FDA Law

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

FDA Law

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic Community 52

FDA Law

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). As to the testing facility inspections, without more explanation than was provided in the preamble, it is not clear how section 513(a)(1)(C) provides authority. Part 860.

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law

MAY 25, 2022

The safety communication acknowledges that the tests “may provide useful information to assess the risk that a fetus has (or does not have) a genetic abnormality.” However, even with a low PPV, a test can provide clinically useful information to providers and patients.

Provider 40

Provider Screening Medical Patients 40

FDA Law

APRIL 14, 2022

De Novo Requests: In the MDUFA IV commitment letter, FDA’s performance goal for review of de novo requests started with review of 50% of requests received in FY 2018 within 150 days of receipt, and increased 10% per fiscal year, ending with 70% within 150 days in FY 2022. By McKenzie E.

Provider 40

Provider Clinic Medical IT 40

FDA Law

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.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

CDOCS

MARCH 31, 2021

& Below, a breakdown is provided for the number of appointments needed in the analog workflow (three appointments) compared to the digital CEREC Primescan iJIG workflow (one appointment).& Take clinical photos (7)<br /> 4. Send materials to the lab with clinical photos.</span></p>

Appointment 52

Appointment Family Families Patients 52

GeriPal

JUNE 8, 2023

Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. If in your own work, your clinical work, is this something that you see people struggle with you, you see yourself struggle with? Goldilocks zone). Listen in to learn more! Nadine: I do.

Diabetes 74

Diabetes Management Patient-Centered Family 74

PEMBlog

MAY 11, 2023

Pediatr Emerg Care This randomized, double-blinded, placebo-controlled trial in infants 0-3 months old getting an LP, younger than 3 months, presenting to the ED meeting clinical criteria for LP. Neither HR nor NCFS differed, and perception of pain by provider, and need for additional lidocaine were similar. 3.93; p = 0.04).

Patient-Centered 52

Patient-Centered Provider IT Patients 52

FDA Law

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). The endpoints must be novel (i.e.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. 21 U.S.C. § 802(54)(D)(i).

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

FDA Law

OCTOBER 5, 2022

eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing. The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps. add-to-files). add-to-files). form construction, auto filling).

Electronics 45

Electronics Medical Screening IT 45

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law

MAY 17, 2022

FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. Usually FDA’s lobbying activities are done rather quietly.

IT 40

IT Patients Provider Individual 40

Physician's Weekly

JUNE 19, 2025

The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65. “We step into places where other providers may not, and geriatrics is a prime example of that.” A headband was tied around her white hair.

Nurse Practitioner 52

Nurse Practitioner Family Families Primary Care 52

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. Going into patient’s homes was eye opening. Their job was done.

Community 116

Community Transportation IT PCP 116

GeriPal

OCTOBER 24, 2024

And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. Summary Transcript CME Summary Cannabis is complicated. It can mean many things, including a specific type of plant, the chemicals in the plant, synthetic analogs, or products that have these components.

Medical 100

Medical IT Patient-Centered Healthcare 100

GeriPal

SEPTEMBER 7, 2023

Based on this surge in evidence, the American Society of Clinical Oncologists recently updated their guidelines for care of older adults to state that all older adults receiving systemic therapy (including chemo, immuno, targeted, hormonal therapy) should receive geriatric assessment guided care. Mazie, welcome to GeriPal. Alex: Thank you.

Patient-Centered 130

Patient-Centered IT Patients Clinic 130

FDA Law

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit). This has been a decision we’ve been closely following. What do we mean?

Clinic 98

Clinic IT Private Practice Utilities 98

Physician's Weekly

JUNE 19, 2025

Independent Association The study involved analysis of data from 43,842 adults in the National Health and Nutrition Examination Survey (NHANES, 1999-2018). Clinical Implications “Higher DII is independently associated with an increased risk of CHD, potentially through pathways involving metabolism, lipid levels, and kidney function.

Hypertension 52

Hypertension Individual Diabetes Diagnose 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives. Dr. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic.

Community 52

Community Patient-Centered Mental Health Board-Certified 52