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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.

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FDA HIPAA Compliance 60

Health Law Advisor

JANUARY 31, 2023

On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., The ODE, per the Orphan Drug Act prevents FDA from approving another applicant’s same drug for “the same disease or condition.” Becerra.” [1] Becerra.” [1]

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FDA 52

Health Law Advisor

SEPTEMBER 5, 2023

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. On August 15, 2023, the U.S.

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Informed Consent FDA 52

HIT Consultant

SEPTEMBER 7, 2021

Food and Drug Administration (FDA) in 2014, as the first-ever computer vision software for surgical use, and several follow-on 510(k) clearances. Gauss’s flagship product, Triton, leverages computer vision to detect surgical and obstetric hemorrhage in real-time and notifies clinicians who can enact timely intervention and treatment.

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McGuire Wood

OCTOBER 12, 2023

Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety requirements for medical devices. To strengthen the QSR metrics, the FDA recommends implementing a secure product development framework (SPDF) to address cybersecurity risks. 27, 2023, the U.S.

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FDA Governance Compliance 52

Bill of Health

JUNE 12, 2024

The practicality I’ve noticed over the years is that no matter what we aim at, there’s the very severe, shorter-term FDA trial. In 2014 CRISPR gene drives. GC: It has piqued my interest for many years. If you look at gene therapies, I’ve been kind of a vocal opponent and advocate of gene therapies for rare diseases.

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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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Healthcare Law Today

JANUARY 11, 2023

The government alleged that, between April 2014 and April 2019, Jet Medical introduced devices into interstate commerce that were misbranded under the Federal Food, Drug and Cosmetic Act (FDCA) because Jet Medical did not obtain approval or clearance from the U.S. Food and Drug Administration (FDA) prior to distribution.

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FDA Governance Medicare Medicare 59

HIT Consultant

JULY 31, 2023

Figure 2 showcases the VC funding landscape for digital pathology from 2014-2022. Figure 2: Public VC Funding for Digital Pathology Vendors 2014-2022 in USDM. Table 1: Topmost funded DP vendors 2014-2022. USD in 2022, with around 50% of that attributed to machine learning and more sophisticated algorithms.

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COVID-19 FDA 96

SQA

SEPTEMBER 2, 2022

United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. The FDA is announcing the availability of a draft guidance for industry entitled Conducting Remote Regulatory Assessments, Question and Answers.

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FDA COVID-19 Nursing Homes Public Health 91

HIT Consultant

OCTOBER 29, 2024

Deep TMS has been successful in treating patients aged 22 to 68 since 2014. And now studies have shown that it is effective for older adults as well, leading to its FDA label expansion for late-life depression in patients ages 68-86. The treatment can be used alone or in conjunction with medication and/or talk therapy.

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FDA Public Health 98

HIT Consultant

DECEMBER 9, 2024

Founded in 2014 and headquartered in the San Francisco Bay Area, Cala Health is backed by leading healthcare and technology investors and is developing therapies in neurology, cardiology, and psychiatry.

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Medicare Medicare FDA 52

Healthcare IT Today

FEBRUARY 26, 2023

billion total transactions since 2014. RapidAI received FDA 510(k) clearance for Rapid RV/LV , which helps physicians assess pulmonary embolism severity. Diagnostic testing platform ixlayer joined the BrightInsight Ecosystem of regulated medtech and biopharma products.

Medicaid 81

Medicaid Medicaid FDA Health Insurance 81

Health Law Advisor

FEBRUARY 1, 2023

Introduction Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar.

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FDA Compliance 52

Health Populi

FEBRUARY 21, 2023

This has been a consistent health consumer sentiment for a long time: here’s how I covered PwC’s study on The Wearable Future back in 2014. ” As employers increasingly pay attention to worker wellness and population health, the enterprise-coverage vision that PwC began to quantify in 2014 is (finally) gaining traction.

Medical Device Industry 62

Medical Device Industry Medicare Medicare FDA 62

HIPAA Journal

OCTOBER 21, 2022

Keith Ritson, 42, of Bayville, New Jersey, is a former pharmaceutical sales representative who promoted compound prescription medications and other drugs between 2014 and 2016.

Fraud 63

Fraud HIPAA FDA Health Insurance 63

Hall Render

JULY 17, 2024

Could FDA Action Be Next? senators sent a letter to the Food and Drug Administration (“FDA”) urging the agency, which has jurisdiction over the advertising of prescription drugs, to update its guidelines on social media advertising. The FDA has not updated its guidance since 2014. In February 2024, two U.S.

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FDA Compliance 40

Redox

MARCH 11, 2020

And the percent of US users climbed from 9% in 2014 to 33% in 2018, according to Accenture. Next-generation health trackers are more trustworthy than the consumer health bands that popped up a decade ago, with a growing number receiving FDA clearances. Supporting day-to-day clinical decisions.

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Doctors FDA Hospitals 52

HIT Consultant

DECEMBER 8, 2022

In 2014, a research team at Johns Hopkins found that U.S. – Streamlined delivery management and cart count processes, including support for multiple replenishment methods so staff can more easily capture product ID, expiration date and lot serial numbers, and quickly identify and verify locations as well as FDA-recalled items.

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Hospitals FDA 52

Hall Render

JANUARY 3, 2024

from the University of Dayton School of Law in 2014. office and helps clients navigate the complex and ever-changing landscape of FDA regulation. Matt graduated with his J.D. Katherine Schwartz focuses her legal practice on fraud and abuse analyses related to the federal Stark, Anti-Kickback and Civil Monetary Penalties laws.

Fraud 40

Fraud Hospitals Compliance FDA 40

SQA

DECEMBER 16, 2022

26 of 2014. United States Food and Drug Administration (FDA) – Regulations and guidance. The FDA is issuing a draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.

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FDA Compliance COVID-19 Licensing 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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FDA Licensing Hospitals Medicaid 98

HIT Consultant

DECEMBER 6, 2023

What You Should Know: Mosie Baby, a pioneering at-home fertility care company, has secured FDA Class II clearance for its Mosie Baby Kit making it the first and only FDA-cleared over-the-counter kit for use in intravaginal insemination (IVI).

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FDA 98

SQA

AUGUST 2, 2021

ISO 18082:2014, Anesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low pressure connectors for medical gases. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

Health Law Advisor

AUGUST 1, 2023

As discussed in our June Insight , earlier this year FDA publicly announced its development of a proposed rule that would expressly define laboratory developed tests (“LDTs”) as medical devices and subject them to the agency’s regulatory authority.

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FDA 98

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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FDA Compliance 52

Bill of Health

AUGUST 29, 2022

Bureau 1, 2 (2014); Robert B. Omicron Surge , Bloomberg (Dec. 31, 2021), [link] (describing a record number of pediatric COVID-19 hospitalizations due to the omicron variant). [2] 2] E.g. , Racial Disproportionality and Disparity in Child Welfare , Dep’t Health & Hum. & Fams., 3] Bell, supra note 99 at 26. [4]

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SQA

MAY 24, 2023

As in the past, the PCPC stands ready to collaborate with the FDA and other stakeholders to ensure any reorganization enables the beauty and personal care industry to continue to provide innovative, safe, and effective products while maintaining consumer trust. The PCPC looks forward to working with FDA Chief Scientist Namandjé Bumpus, Ph.D.,

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2024

68: Risk-Based Approach for Prevention and Management of Drug Shortages was originally developed in 2014. Parenteral Drug Association (PDA) – Technical Reports Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages, May 2024 PDA Technical Report No.

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FDA Compliance Public Health World Health 52

SQA

AUGUST 8, 2023

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. The measure may allow the expansion of the population’s access to diagnostic procedures in the country.

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FDA Compliance COVID-19 World Health 40

SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). FDA plant inspection and pay $50 million in fines and forfeiture. The deadline for comments is 30 June 2021.

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COVID-19 FDA COVID-19 Vaccine Compliance 52

SQA

JULY 8, 2022

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13.

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Pharmaceutical Industry FDA Hospitals World Health 40

Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

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FDA COVID-19 Compliance Governance 52

SQA

FEBRUARY 26, 2024

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. PCPC provided feedback to the FDA on the development of an efficient electronic submission program (Cosmetics Direct) and recognizes that the FDA’s development of Cosmetics Direct is ongoing.

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FDA Compliance COVID-19 Public Health 52