Fierce Healthcare

JANUARY 4, 2023

FDA rule allows retail pharmacies to dispense abortion pills. Wed, 01/04/2023 - 08:12.

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FDA 105

Bill of Health

SEPTEMBER 22, 2022

Aparajita Lath is a Master of Laws student (LLM 2023). Sanjay’s research interests include pharmaceutical competition, FDA regulatory reform, and health care coverage. The post Petrie-Flom Welcomes 2022-2023 Student Fellows appeared first on Bill of Health.

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Bioethics FDA Governance 130

Fierce Healthcare

MARCH 16, 2023

FDA's Califf calls on insurers to help providers participate in critical clinical drug trials rking Thu, 03/16/2023 - 11:55

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FDA 98

Fierce Healthcare

JANUARY 31, 2023

Former Oracle exec Troy Tazbaz tapped as FDA director of digital health aburky Tue, 01/31/2023 - 15:29

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FDA 103

Health Law Advisor

MARCH 14, 2023

In a March 6, 2023 constituent update , the U.S. Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of ingredient information that was previously found on different FDA webpages.”

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FDA 52

Bill of Health

APRIL 21, 2023

FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. 2023 Mar 6;20(3):e1004190. Eroding Judicial Deference to the FDA – Consequences for Public Health. 2023 Mar 16;388(11):963-966. 2023 Mar 3;4(3):e230217. 2023 Mar 6:S1098-3015(23)00062-1. 2023 Mar 21.

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COVID-19 Vaccine FDA COVID-19 Public Health 144

Fierce Healthcare

JANUARY 24, 2023

Providers jostle to lead way if FDA makes COVID vaccination a yearly jab fdiamond Tue, 01/24/2023 - 08:46

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FDA 98

Bill of Health

JUNE 20, 2023

Melflufen: post-hoc subgroup analyses and the US FDA Oncologic Drugs Advisory Committee. 2023 May;10(5):e314-e317. Physician Perspectives on FDA’s Decision to Grant Accelerated Approval to Aducanumab for Alzheimer’s Disease. 2023 May 23. 2023 May 22:e231245. 2023 May 9;381:e072796. BMC Cancer.

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FDA Hospitals 144

Bill of Health

MARCH 27, 2024

By Vincent Joralemon As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. This is typical—without a seal of approval from FDA, insurers are reluctant to pay for off-label treatments. for depression).

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FDA Medicare Medicare Health Insurance 201

McGuire Wood

OCTOBER 12, 2023

27, 2023, the U.S. 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.

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FDA Governance Compliance 52

Dot Compliance

NOVEMBER 2, 2022

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. Compliance Dashboard, Inspections, FDA, accessed October 3, 2022, [link] cd/inspections.htm ). In its February 2022 report, the U.S.

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FDA COVID-19 Compliance Governance 52

Health Law Advisor

SEPTEMBER 5, 2023

On August 15, 2023, the U.S. 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.

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Informed Consent FDA 52

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

MARCH 3, 2023

On February 22, 2023, the U.S. Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives. [1] However, FDA found that consumers do not appear to understand the nutritional differences between plant-based milk and cow-derived milk.

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FDA Governance 52

Healthcare It News

DECEMBER 16, 2022

What does 2023 hold for healthcare technology, as innovation continues at rapid speed, policymakers and regulators try to keep up with the pace of change – and health systems large and small deal with significant budgetary shortfalls that could hamper their ability to build out their digital transformation efforts?

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COVID-19 Public Health Ransomware FDA 294

Health Law Advisor

MARCH 1, 2023

To provide more value to readers, I’ve started submitting FOIA requests for unpublished data to produce additional insights into how FDA works. And what better first topic than data on FDA responses to FOIA requests. FDA has been releasing data on its FOIA process, specifically its FOIA logs , for a few years. We were wrong.

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FDA Governance 52

HIT Consultant

JULY 22, 2022

What You Should Know: – Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch. iRhythm plans to introduce the ZEUS System for a limited market evaluation in 2023.

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FDA 97

Verisys

DECEMBER 12, 2023

Compliance Updates: December 2023 Overlook: Federal Legislation DEA Licensure Compacts Other Legislation Board Updates Federal Legislation: The TREATS Act has been proposed which would amend the Controlled Substances Act to allow for the use of telehealth in substance use disorder treatment. Collaborative Practice ( 680-X-2-.44

Regulatory Compliance 52

Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

Bill of Health

APRIL 24, 2023

Dmitry’s talk, “Evergreening: The FDA’s Role in the Creation of Balanced Rights for Pharmaceutical Improvements,” was developed into an article and published in the Iowa Law Review in 2019 titled “The More Things Change: Improvement Patents, Drug Modifications, and the FDA.”

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Public Health FDA Bioethics Governance 313

Fierce Healthcare

APRIL 7, 2023

Texas judge suspends FDA approval of abortion pill but gives HHS time to appeal rking Fri, 04/07/2023 - 19:38

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FDA 59

Hall Render

AUGUST 31, 2023

On August 16, 2023, a three-judge panel of the Fifth Circuit Court of Appeals issued an opinion in the ongoing litigation regarding the U.S. Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. Jackson Women’s Health.

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FDA COVID-19 40

Hall Render

SEPTEMBER 15, 2023

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to be 5-HT2 agonists (e.g.,

FDA 40

FDA Licensing Compliance 40

Hall Render

SEPTEMBER 14, 2023

On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices.

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FDA Informed Consent COVID-19 Fraud 40

HIT Consultant

NOVEMBER 24, 2022

First, let’s examine the new regulatory framework the FDA established. Beginning later this year and continuing into the first half of 2023, however, these products will likely start to appear. – What new opportunities will arise? – What potential pitfalls should they be aware of? Introducing OTC hearing aids.

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FDA Public Health Medicare Medicare 98

HIT Consultant

APRIL 4, 2023

What You Should Know: 2023 started off with the hallmarks of a rebound year. Q1 Funding Soars, But 2023 May Struggle to Catch Up to 2019 Q1 2023 U.S. If funding for the next three quarters matches the average funding across the prior three quarters, 2023 is on pace for the lowest level of annual funding since 2019.

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FDA Medicaid Medicaid COVID-19 52

Healthcare IT Today

JUNE 10, 2023

Factors including FDA approval, a clear value proposition, demonstrated ROI, and an understanding of regulatory processes can all work in a founder’s favor. Hone care vendor Tytocare received FDA approval for a product that analyzes lung sounds captured a handheld device. Navigating Long Buying Cycles in Healthcare Innovation.

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FDA Compliance Licensing Hospitals 95

Hall Render

SEPTEMBER 6, 2023

After no enforcement actions for the first six months of 2023, enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is heating up with two new letters issued in the month of August. Below is a summary of key takeaways from the letters.

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FDA 40

SQA

JULY 19, 2023

This year, their target is 100+, and they are not far off from that pace, averaging 1 launch every 4 days in 2023. Elon’s goal, however, was to increase to a rate of 2-3 launches per week. Last year, SpaceX successfully completed 61 launches.

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FDA 98

Healthcare IT Today

JANUARY 6, 2023

As we head into 2023, we wanted to kick off the new year with a series of 2023 Health IT predictions. We have seen unprecedented growth in the digital healthcare space and this momentum will only continue in 2023 – bringing more innovation, smarter technology, and impactful legislation and business initiatives.

US Department of Health and Human Services 104

US Department of Health and Human Services Doctors Telemedicine Public Health 104

Bill of Health

OCTOBER 11, 2023

2023 Aug 22. 2023 Aug 21:e232842. 2023 Aug 21. 2023 Aug;176(8):1047-1056. 2023 Aug 17:e2314414. 2023 Aug 24;389(8):682-684. 2023 Aug 2. Changes in the Number of Continuation Patents on Drugs Approved by the FDA. 2023 Aug 1;330(5):469-470. 2023 Aug 29. Ann Intern Med. N Engl J Med.

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Patient Advocacy Medicare Medicare FDA 144

Mobi Health News

DECEMBER 13, 2022

The company said it plans to launch the latest model of its CGM in early 2023.

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FDA 126

Hall Render

OCTOBER 5, 2023

On August 15, 2023, the U.S. 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. study sponsor, regulatory agencies, etc.)

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Informed Consent FDA Compliance Regulatory Compliance 40

Hall Render

FEBRUARY 7, 2023

On January 3, 2023, the U.S. February 9, 2023 UPDATE : A number of lawsuits have been filed challenging FDA’s approval of mifepristone and the REMS. Overview Since 2000, mifepristone (brand name Mifeprix) has been FDA approved for the medical termination of pregnancy through ten weeks’ gestation.

FDA 40

FDA COVID-19 Public Health Governance 40

Health Law Advisor

JANUARY 31, 2023

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact. 343(w)(1)).

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FDA 52

Healthcare IT Today

MAY 6, 2023

Advances in wearable technology coupled with rising cases of hypertension have motivated research, but many scientific, regulatory, commercial and engineering risks stand in the way of a cuffless BP monitor gaining FDA approval , said Steven LeBoeuf, Ph.D., at Valencell.

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Fraud Doctors Medicare Medicare 92

Healthcare IT Today

MAY 20, 2023

That’s why the Connected Health Initiative advocates on behalf of all health IT vendors on issues ranging from reimbursement to interoperability to FDA regulation, Colin learned in a conversation with CHI’s Brian Scarpelli. Legislation and policymaking are a black box for most people. million Series A funding round.

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Ransomware Telemedicine Public Health FDA 97

Bill of Health

MARCH 24, 2023

2023 Feb 25;S0012-3692(23)00301-X. 2023 Feb 7;329(5):386-392. 2023 Feb 13:e226444. 2023 Feb 3;4(2):e225610. Assessment of FDA-Approved Drugs Not Recommended for Use or Reimbursement in Other Countries, 2017-2020. 2023 Feb 13:e226787. 2023 Feb 23. 2023 Feb 14;329(6):459-460. JAMA Intern Med.

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Medicare Medicare Medicaid Medicaid 144