Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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FDA HIPAA Compliance 113

Bill of Health

APRIL 21, 2023

FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. A full posting of abstracts/summaries of these articles may be found on our  website. Eroding Judicial Deference to the FDA – Consequences for Public Health. public investment in the development of mRNA COVID-19 vaccines.

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COVID-19 Vaccine FDA COVID-19 Public Health 144

Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. For example, in furtherance of the laudable goal of enhancing access and affordability of hearing healthcare, the FDA does not require that a hearing health professional verify a member’s hearing loss to be eligible for an OTC device. Introducing OTC hearing aids.

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Bill of Health

DECEMBER 20, 2022

FDA Approval. Food and Drug Administration (FDA), which “ regulates the sale of medical device products (including diagnostic tests) in the U.S. ” Although it is questionable whether the FDA would ever approve the Sarco machine as a medical device, it turns out the FDA may not need to. .”

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FDA Doctors Informed Consent Bioethics 245

Electronic Health Reporter

APRIL 6, 2023

This article is copyrighted strictly for Electronic Health Reporter. Food and Drug Administration (FDA) for use in the general population. Illegal copying is prohibited. Investigational medicines are drugs or treatments not approved by the U.S.

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FDA 103

Bill of Health

JULY 1, 2022

A full posting of abstracts/summaries of these articles may be found on our? Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Fixing The FDA’s Orange Book. Bloomfield D, Lu Z, Kesselheim AS. Health Aff (Millwood). 2022 May;41(5):713-721. Health Aff (Millwood).

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Bill of Health

OCTOBER 7, 2022

Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our?

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Prescription Drug Pricing FDA Medicare Medicare 130

Bill of Health

JUNE 20, 2023

A full posting of abstracts/summaries of these articles may be found on our  website. Melflufen: post-hoc subgroup analyses and the US FDA Oncologic Drugs Advisory Committee. Physician Perspectives on FDA’s Decision to Grant Accelerated Approval to Aducanumab for Alzheimer’s Disease. Lancet Haematol.

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Bill of Health

OCTOBER 28, 2022

A full posting of abstracts/summaries of these articles may be found on our? Dose modification rules and availability of growth factor support: A cross-sectional study of head-to-head cancer trials used for US FDA approval from 2009 to 2021. FDA validation of surrogate endpoints in oncology: 2005-2022. JAMA Intern Med.

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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S. study sponsor, regulatory agencies, etc.)

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Informed Consent FDA Compliance Regulatory Compliance 40

Bill of Health

DECEMBER 14, 2022

In a recent article, Normalizing Reproductive Genetic Innovation , I offer four potential avenues for structuring a societal discourse in the U.S. Food and Drug Administration (FDA). For example, physicians and companies offering cytoplasmic and mitochondrial transfer have received Untitled Letters from the FDA. on the topic.

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FDA COVID-19 Vaccine COVID-19 Bioethics 205

Hall Render

AUGUST 31, 2023

Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a decision by a District Court judge in Texas that would have suspended the FDA’s approval of mifepristone. Jackson Women’s Health.

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Hall Render

FEBRUARY 7, 2023

Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”).

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FDA COVID-19 Public Health Governance 40

Hall Render

MAY 11, 2022

Earlier this year, the Food and Drug Administration (“FDA”) announced a Proposed Rule regarding national standards for the licensing of prescription drug wholesale distributors (“Wholesale Distributors”) and third-party logistics providers (“3PLs”). Accordingly, FDA is proposing the withdrawal and replacement of the current 21 C.F.R.

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Licensing FDA 40

Hall Render

SEPTEMBER 8, 2023

Under the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations , “drug promotional labeling and prescription drug advertising must be truthful and non-misleading, convey information about the drug’s efficacy and its risks in a balanced manner and reveal material facts about the drug.”

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FDA Public Health 40

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

FDA 60

FDA HIPAA Compliance 60

Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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FDA Licensing Compliance 40

Mobi Health News

FEBRUARY 22, 2021

An article in NEJM reports that pulse oximeters missed occult hypoxemia in more Black patients than white.

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FDA 144

Bill of Health

NOVEMBER 17, 2022

A full posting of abstracts/summaries of these articles may be found on our? Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. Limitations on the Capability of the FDA to Advise. Brown BL, Mitra-Majumdar M, Darrow JJ, Moneer O, Pham C, Avorn J, Kesselheim AS. JAMA Intern Med.

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Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

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COVID-19 FDA Medical Device Industry Public Health 52

Exeed Regulatory Compliance

MARCH 22, 2020

A new FDA guidance provides much-needed relief during a pandemic. FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.

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FDA Nursing Homes Compliance COVID-19 52

Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. In this article, we will cover Face Shields and Respirators. References FDA (2020, May).

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COVID-19 FDA Medical Device Industry Public Health 52

Bill of Health

MARCH 13, 2023

This article reviews recent instances of the issue, and discusses relevant regulations. The FDA’s primary responsibility is over claims that appear on product labels (including packaging, product inserts, and promotional material at the point of sale), and the FTC regulates claims made in advertising in general.

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FDA COVID-19 Public Health 184

Bill of Health

AUGUST 26, 2022

A full posting of abstracts/summaries of these articles may be found on our? Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review. Recalls, Availability, and Content of Dietary Supplements Following FDA Warning Letters. J Health Polit Policy Law. 2022 Jul 14:10041093.

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Healthcare IT Today

MAY 5, 2024

This article will be a weekly roundup of interesting stories, product announcements, new hires, partnerships, research studies, awards, sales, and more. Products GE HealthCare announced FDA 510(k) clearance for Portrait VSM , its portable vital sign monitor. Welcome to the weekly edition of Healthcare IT Today Bonus Features.

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FDA Medicare Medicare Hospitals 96

Exeed Regulatory Compliance

FEBRUARY 25, 2020

Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification. the FDA expects for interoperable devices.

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FDA 52

Electronic Health Reporter

DECEMBER 3, 2019

This article is copyrighted strictly for Electronic Health Reporter. In the past two years, the FDA approved two autologous cell and gene therapies, Kymriah and Yescarta. The article Key Tenets of A Personalized Medicine Orchestration Platform appeared first on electronichealthreporter.com. Illegal copying is prohibited.

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FDA 116

Bill of Health

MARCH 25, 2022

A full posting of abstracts/summaries of these articles may be found on our? Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. Bakker E, Hendrikse NM, Ehmann F, van der Meer DS, Llinares Garcia J, Vetter T, Starokozhko V, Mol PGM. 2022 Feb 24. Epub ahead of print.

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FDA COVID-19 Medicaid Medicaid 205

Electronic Health Reporter

JULY 19, 2019

This article is copyrighted strictly for Electronic Health Reporter. Food and Drug Administration (FDA), shortages continue to increase. The article Transforming How Hospitals Identify and Manage Drug Shortages appeared first on electronichealthreporter.com. Illegal copying is prohibited. health care system.

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Hospitals FDA 125

Electronic Health Reporter

JANUARY 4, 2019

The approval of electrocardiogram’s (EKG) through the FDA that enables atrial fibrillation detection right from a patient’s watch band is just one example of how the digitization of medical devices, a part of the Internet of Things movement, is leading product development and innovation in medicine. However, while medical devices […].

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FDA 158

Bill of Health

OCTOBER 11, 2023

The selections feature topics ranging from a review of the regulatory consequences of the FDA’s accelerated approval of eteplirsen, to a comparison of the safety and effectiveness of generic and brand-name fluticasone-salmeterol for COPD, to an analysis of free speech challenges to Medicare drug price negotiation under the Inflation Reduction Act.

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Patient Advocacy Medicare Medicare FDA 144

Electronic Health Reporter

DECEMBER 27, 2018

The approval of electrocardiogram’s (EKG) through the FDA that enables atrial fibrillation detection right from a patient’s watch band is just one example of how the digitization of medical devices, a part of the Internet of Things movement, is leading product development and innovation in medicine. However, […].

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FDA 132

Electronic Health Reporter

MAY 8, 2019

This article is copyrighted strictly for Electronic Health Reporter. Last October, the FDA released a major update to its premarket cybersecurity guidance for medical devices, publishing guidelines that […]. The article MedCrypt Announces $5.3 Illegal copying is prohibited.

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FDA 96