U.S. Food and Drug Administration
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Non-profit Sues FDA, Requesting the Agency Withdraw Approval for Abortion Drugs
The group complains that the FDA never studied the safety of the drugs under the labeled conditions of use.
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Debunking 8 commonly held CAPA myths
Here’s a compilation of myths and realities about Corrective Action and Preventive Action (CAPA), the system for addressing systemic quality issues for medical device companies.
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Streamline the Process for Consent Collection and Management
Join us on April 16th and hear executives from DocuSign and Velatura discuss how their partnership modernizes and facilitates the efficient and secure completion of the patient consent form.
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What should trigger a CAPA in medical device manufacturing?
Corrective Action and Preventive Action (CAPA), a system for addressing systemic quality issues for medical device companies, is frequently overused, which can overburden businesses with unnecessary work, or when underutilized, trigger FDA warning letters.
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Trump lays out health insurance reform plan, calls for streamlined FDA
Trump also called for reforming the “slow and burdensome” FDA drug approval process.
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Ex-FDA boss Califf optimistic about 21st Century Cures, skeptical of Trump
Dr. Robert Califf, who stepped down last month, offers five tips about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency.
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Pharma companies routinely bend orphan drug rules
A Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions.
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Consumer tech companies developing OTC hearing aids
Several recent developments are of note as consumer electronics companies, hearing aid manufacturers, audiologists, physicians, consumer advocates and regulators prepare for a surge of new hearing devices and changes in the hearing healthcare system.
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Startup Arterys wins FDA clearance for AI-assisted cardiac imaging system
Arterys Inc.’s Cardio DL program applies artificial intelligence to automate tasks that radiologists have been performing manually.
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Do you advise self-insured employers? You Can Help Us!
Take part in this survey and share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health and navigation.
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In Congress, HHS nominee Tom Price intervened for healthcare donors
Price has been a go-to congressman, a review of his records show, for medical special interests hotly sparring with regulators or facing budget cuts.
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Health IT startups working to secure pharma supply chains?
Several technology companies have developed ways to protect the pharmaceutical supply chain and support track and trace technology so counterfeit drugs can be easily spotted and identified.
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3D printing’s march in healthcare continues
Analysts have predicted that 3D printing will be a major disruptive force in the healthcare industry before the end of the decade.
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Cosgrove to advise Trump as health executive revolving door spins
Cleveland Clinic CEO Dr. Toby Cosgrove will be one of 16 business leaders on President-elect Donald Trump’s President’s Strategic and Policy Forum, while Zenefit’s David Sacks may join Trump’s transition team, plus Apple loses a top health exec.
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Infection-related deaths expose deficiencies in FDA oversight of medical devices
At least 79 cases of infection tied to Sorin heater-cooler units in the U.S. and worldwide have been reported to the FDA since 2010, including 12 deaths. Those numbers are expected to rise.
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ACA repeal, CHIP renewal could top Trump’s healthcare agenda
Here are some of the major health issues that are certain to come up in 2017.