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Pearl Therapeutics, Inc.

Latest From Pearl Therapeutics, Inc.

Coming Together On Pre-Cert: Digital Health World Engages With FDA To Hash Out Regulatory Future

US FDA, industry and other digital health stakeholders huddled at the National Institutes of Health for two days of deep discussions around how the Pre-Certification Pilot was advancing, and how the agency should implement a program that emphasizes certifying "excellence" in company processes. Check out coverage of the meeting and Medtech Insight's exclusive podcast interview with FDA project lead Bakul Patel.

Digital Health Regulation

Win For AZ's COPD Triple Combo In Bid To Catch GSK

GlaxoSmithKline is streets ahead in the three-in-one COPD market, having received approval last year in the USA and Europe for Trelegy Ellipta, but AstraZeneca's PT010 may provide competition in the future having met six out of seven lung function primary endpoints in a Phase III trial.

Clinical Trials Respiratory

2018 An Inflection Point For mHealth After An Active Year

The past year saw US FDA and industry work hard and fast to prepare for what looks like an inevitable boom in the digital-health sector. According to interviews, the time is ripe for adoption of mobile health apps to help reduce health-care costs, but the brave new world also brings with it big challenges.

Digital Health Cybersecurity

Five Takeaways From Commissioner Gottlieb's Talk At The National Press Club

Among the topics US FDA Commissioner Gottlieb touched on were the agency's efforts to reduce clinical development burdens, improve information-sharing and comply with President Trump's two-for-one regulations order.

Regulation FDA
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