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


U.S. House passes bill to lengthen time to report medical device malfunctions

Man looking at machine with clipboard“The U.S. House passed a fee-reauthorization bill for the Food and Drug Administration on Wednesday that would triple the amount of time medical device companies have to report malfunctions of some higher-risk product. The change, outlined in a statement included by reference in the bill, would give companies 90 days to report product malfunctions, replacing the current 30-day deadline. The bill would also allow companies to summarize previously reported product malfunctions, rather than filing detailed reports on each case.”

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House passes bipartisan FDA user fee bill

FDA“The bill calls for more than $400 million in new user fees in fiscal 2018, and would incrementally increase fees each year thereafter. It would allow the FDA to hire more staffers and speed up approvals of drugs and devices, which could help healthcare companies streamline operations, supporters argue. Yet, critics claim that the rising fees disproportionately affect smaller companies, and expediting the review of drugs and medical devices could compromise quality.”

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The Growing Role of Automation in the Pharmaceutical Industry

cGMP“Automation in the laboratory has been around for decades, but historically accessibility and ease of use was reserved for high value processes. One example, in the pharma industry, is using liquid handling robots to improve reproducibility and increase the validity of data in high throughput screening (HTS). This is because automated systems are less likely to have variances in reagent quantities and HTS is a fairly consistent and repetitive process.”

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5 Trends Driving Disruption in the Med Device Industry in 2017

people working machinery“The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them.”

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How the FDA has changed, How the 483 has changed, & How we should use 483s to get smarter

“The most important change over the past ten years has been the FDA’s shift to become globally active in GMP enforcement as the drug supply chain changes. Some of the countries to which manufacturing is outsourced have differing interpretations of US GMPs and have regulatory authorities that may not be as mature as, for example, the FDA or EMA. The FDA is not the only regulatory authority impacted by this change.   As a result we see the FDA collaborating with other regulatory agencies, such as the EMA, so that both may make most effective use of their resources.”

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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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The FDA Re-Org Has Begun. What Does it Mean for You?

“The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products.  Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.”

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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 Devices“Medicine 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

FDA“FDA 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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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


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?