PATHWISE INDUSTRY NEWS

Read important industry news with the latest articles on life sciences, manufacturing, and regulatory issues. 

JUNE 2017 INDUSTRY NEWS

Apple Partnership with Medical Device Maker Sign of More To Come

At Apple’s WorldWide Developers Conference in California, the company announced that it would indeed offer users the chance to monitor their glucose levels. The company has partnered with medical device maker Dexcom and will link that company’s glucose monitoring device with the Apple Watch.  The news comes as no surprise as Apple have been steadily positioning itself as a dedicated provider of health and fitness software, namely through its Apple Watch Series. However, whilst Apple has previously marketed itself towards lifestyle and fitness enthusiasts, it has yet to enter the medical device sector.

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CDRH’s Guidance Goals for 2017

CDRH has publicized its resolution list for the new year, issuing an A-list of its top priorities for final and draft guidance in fiscal year 2017. On the list of top subjects to tackle are 12 final guidance topics and four draft guidance topics. These include final guidance on titles like “510(k) Third Party Review Program” and “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices,” as well as both draft and final guidance on “New or revised procedural guidances for MDUFA IV implementation,” among others. CDRH also published a B-list of topics that it hopes to issue if possible, as well as a links to final guidance documents from 1977, 1987, 1997, and 2007. These older guidances are expected to be reviewed with an eye to whether any of them should be revisited or withdrawn.

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Medical device makers are delighted at new FDA plan: ‘Holy smokes’ says one lawyer

QSR Medical DevicesMedicine is going digital and regulators are under pressure to keep pace. The U.S. Food and Drug Administration announced a few months ago that it will create a new unit dedicated to digital health, which will include team of engineers. And on Thursday, the FDA’s recently-appointed commissioner Scott Gottlieb went a step further, outlining in a blog post more steps the agency is going to take. Gottlieb said he’s putting together a “digital health innovation plan” that will lay out how devices will be regulated so that developers have clarity on the rules and don’t have to seek out the FDA’s position on a “case-by-case basis.”

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FDA Launching Innovation Plan

FDAFDA Commissioner Scott Gottlieb said Wednesday the agency is launching a Medical Innovation Access Plan designed to facilitate biomedical innovation. Speaking to the Senate Appropriations Committee’s subcommittee on agriculture, rural development and FDA, Gottlieb positioned the plan as a tool to lower healthcare costs by reducing expenditures on costly diseases. “Ultimately, the most tangible way we’re going to reduce healthcare costs is by finding new and better treatments for vexing diseases like diabetes and cancer and neurodegenerative ailments like Alzheimer’s,” Gottlieb said.

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MAY 2017 INDUSTRY NEWS

FDA commissioner Scott Gottlieb sets some goals: Find ways to lower drug prices, use new tech to speed development

Study: “Safety Events” Common for Drugs and Biologics After FDA Approval

Medicine Is Going Digital. The FDA Is Racing to Catch Up

APRIL 2017 INDUSTRY NEWS

Medical device reporting: Reading between the lines

Critics worry faster FDA drug reviews could compromise safety

Industry response to new EU laws on medical device

Will request for pause in FDA quality metrics plan lead to it being killed as unneeded regulation?

MARCH 2017 INDUSTRY NEWS

New EU medical devices regulations expected to be finalised in April

An Analysis Of FDA FY2016 Drug GMP Warning Letters

Control over production data still tripping up foreign drug manufacturers with FDA