FDA Approves First Implanted Lens Adjustable Post-cataract Surgery to Improve Vision

Sometimes we include a story because it’s simply fascinating: November 22 – “The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better…

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FDA Issues Important New Guidances: Pre-ANDA and Controlled Correspondence

In October of this year, FDA issued guidance that for the first time formalized the Pre-ANDA Meeting for developers of complex generics. Entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products,” “This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has…

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Massachusetts Proposes New Twist On Negotiating Medicaid Drug Costs

US News & World Report recently reported “Massachusetts Grabs Spotlight By Proposing New Twist On Medicaid Drug Coverage Other states are watching closely, officials say.” Following is an excerpt: “In the absence of new federal policies to tame break-the-bank drug prices, Massachusetts’ state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the…

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EMA Drug Post-Marketing Safety Surveillance Changes, US Impact and Compliance Assistance

On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2)…

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Commissioner Gottlieb Reports FDA Easing on Expanded Access INDs; Addresses Sponsor Reluctance

According to Commissioner Gottlieb, “Each year, FDA receives over 1,000 applications for the treatment of patients through expanded access, also known as compassionate use, and the agency authorizes the vast majority (about 99%). FDA recognizes that time is critical for these seriously ill patients who do not have alternative therapies, and who cannot take part in a clinical…

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Real World Evidence in the News

Clinical Informatics News recently reported that “Real-world data sources are combining with traditional data sources—clinical trials, electronic medical records, genomic data, insurance claims, streaming connected devices, social media, meteorological data, and patient reported data—to offer a wealth of possible applications. And now maturing technologies like machine learning and algorithmic methodologies can make sense of these…

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