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Category: Regulatory


Regulatory

FDA chief Scott Gottlieb warns ‘we have many hard decisions ahead of us’ if shutdown persists

January 18, 2019

Via: CNBC

Food and Drug Administration Commissioner Scott Gottlieb warned on Friday that if the partial government shutdown persists, it will force the FDA to make “hard decisions” on preserving key functions of the agency. The FDA cannot accept any new funding […]


Regulatory

Furloughed feds’ health coverage intact, but shutdown still complicates things

January 18, 2019

Via: The Medical News

Joseph Daskalakis’ son was born New Year’s Eve, a little over a week into the current government shutdown, and about 10 weeks before he was expected. Little Oliver ended up in a specialized neonatal intensive care unit, the only one […]


Regulatory

FDA approves scalpel-free Parkinson’s tremor treatment

January 16, 2019

Via: medicaldevice-network.com

The procedure is called focused ultrasound and enables doctors to conduct brain surgery without cutting into a patient’s skull. It was proven to be a safe and effective option for reducing medication-resistant Parkinson’s tremor during clinical trials led by University […]


Regulatory

Walmart pharmacies likely to leave CVS network because of pricing dispute

January 15, 2019

Via: CNBC

Walmart pharmacies are expected to leave the drugstore networks offered by CVS because of an ongoing pricing dispute. Anyone with CVS-administered drug benefits and Medicaid enrollees with CVS drug coverage will be affected if the split happens, CVS said Tuesday. […]


Innovation, Medical Devices, Regulatory

Abbott’s heart defect treatment device for babies gets FDA approval

January 15, 2019

Via: medicaldevice-network.com

PDA is a common congenital cardiac defect that is characterised by an opening between two blood vessels leading from the heart, resulting in difficulty in breathing. Of the 60,000 premature babies born each year in the US, approximately 12,000 have […]


Regulatory

FDA issues 5-year plan to make its Sentinel system more robust

January 11, 2019

Via: Health Data Management

The Food and Drug Administration wants to ensure that its post-market monitoring of drugs and biologics keeps pace with changing drug development and safety ecosystems. Towards that end, the agency has developed a five-year strategy to grow the capabilities of […]


Regulatory

FDA Commissioner Outlines Next Steps for Pre-Cert Digital Health Pilot Program

January 8, 2019

Via: Healthcare Informatics

The U.S. Food and Drug Administration (FDA) has drafted a regulatory framework to test new approaches for the review of digital health device applications. In 2017, the FDA released its Digital Health Innovation Action Plan, while also unveiling a new […]


Innovation, Medical Devices, Regulatory

FDA moves to modernise medical device approval after safety scandals

January 4, 2019

Via: medicaldevice-network.com

This change was announced following the International Consortium of Investigative Journalists (ICIJ) report on over 80,000 deaths in the US associated with defective medical devices over the last 10 years. With globally increasing rates of medical device usage, these technologies […]


Opinions, Regulatory

How the government shutdown affects health programs

January 3, 2019

Via: The Medical News

There seems to be no end in sight for the current partial government shutdown, the third since the beginning of the Trump administration. For the vast majority of the federal government’s public health efforts, though, it’s business as usual. That’s […]


Regulatory

Trump signs into law maternal mortality prevention legislation

December 27, 2018

Via: Health Data Management

President Trump has signed legislation to prevent U.S. maternal mortality—which has more than doubled since 1987—by funding surveillance, data collection, and research on how to solve the growing problem. The Preventing Maternal Deaths Act, which was passed earlier this month […]


Regulatory

Democrats vow rapid action after ruling casts doubt on ACA

December 17, 2018

Via: Health Data Management

Obamacare was struck down by a Texas federal judge in a ruling that casts uncertainty on insurance coverage for millions of U.S. residents. The judicial ruling is drawing sharp condemnation from medical professional organizations and a vow for immediate legal […]


Regulatory

Obama, Democrats make last push for Obamacare signups as Trump cuts ad budget

December 12, 2018

Via: CNBC

Former President Barack Obama and other high-profile Democrats are on a social media blitz to remind people to sign up for health insurance through the Affordable Care Act before the open enrollment period ends in most states on Saturday. Signups […]


Regulatory

VA partners with 3 companies to boost telehealth services

December 12, 2018

Via: Health Data Management

The Department of Veterans Affairs is enlisting partners in an effort expand telehealth services to the nation’s veterans. The agency has announced several industry partnerships in a program to enhance its connected care program, offering growing support for the use […]


EHR & EMR, Regulatory

FDA issues new framework to advance use of real-world data

December 7, 2018

Via: Health Data Management

The Food and Drug Administration is expanding its use of real-world data—such as electronic health records, medical claims and registries—to improve regulatory decisions regarding drugs and biologics. “Because they include data covering the experience of physicians and patients with the […]


Regulatory

FDA proposes more transparent de novo pathway for medical devices

December 5, 2018

Via: medicaldevice-network.com

The De Novo pathway is used to review new, low-to-moderate risk devices and determine predicates that assure certain safety and effectiveness measures. The regulatory agency have published the new de novo Classification Proposed Rule involving procedures and criteria associated with […]