N.D. plans to appeal dismissal of lawsuit related to opioid crisis | FDA issues 34 new or updated guidance docs on generics | CMS finalizes drug price transparency rule in MA, Part D
May 17, 2019
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N.D. plans to appeal dismissal of lawsuit related to opioid crisis
N.D. plans to appeal dismissal of lawsuit related to opioid crisis
(John Moore/Getty Images)
North Dakota expects to file an appeal after a judge threw out the state's lawsuit against OxyContin manufacturer Purdue Pharma, Attorney General Wayne Stenehjem said. The lawsuit sought to hold Purdue Pharma responsible in connection with widespread opioid abuse, but the judge said the company lacks control of its product once the drug is on the market.
The Associated Press (5/15) 
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FDA issues 34 new or updated guidance docs on generics
The FDA issued 25 new and nine updated draft guidance documents intended to support development of generic medications including HIV antiretrovirals, antibiotics, ophthalmic drugs, cancer drugs, azelaic acid and ivermectin. The documents offer product-specific recommendations on the design of bioequivalence studies.
Regulatory Focus (5/15) 
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CMS finalizes drug price transparency rule in MA, Part D
The CMS issued a final rule that requires Medicare Advantage and Part D plans to offer a drug cost transparency tool that can be integrated into prescribers' EHRs and also requires Part D plans to share price transparency and low-cost alternative information in monthly letters to beneficiaries. The final rule also bans contract clauses that restrict pharmacist-patient conversations about drug prices, but it does not include measures requiring price concessions to be passed to consumers, nor does it include proposed changes to management of protected drug classes.
Patient Engagement HIT (5/16),  Modern Healthcare (tiered subscription model) (5/16) 
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Administration urges court to reinstate Medicaid work rules in 2 states
A brief filed by HHS and the Justice Department urges a federal appeals court to revive Medicaid work rules in Arkansas and Kentucky, arguing the programs are policy experiments that adhere to Medicaid's mission. "The goal of the policies is to encourage compliance, and the terms and conditions of approval include safeguards intended to minimize coverage loss due to noncompliance," the agencies wrote, adding that the "Supreme Court has long recognized that requirements that enable states to stretch limited resources promote the objectives of public welfare programs."
Modern Healthcare (tiered subscription model) (5/16) 
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Medical Devices
Recall of Ethicon staplers labeled as Class I by FDA
A select recall of Ethicon's Endo-Surgery endoscopic and non-endoscopic staplers with adjustable height staples has been labeled Class I by the FDA. The Johnson & Johnson subsidiary issued the recall following issues with uncut washers and malformed staples caused by insufficient firing.
MassDevice (Boston) (5/16) 
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Masimo's Radius PPG secures FDA clearance
Masimo has received 510(k) clearance from the FDA for its Radius PPG, a Masimo SET-powered tetherless sensor solution to continuously monitor patients while allowing them to move freely. The product makes a cabled connection to a pulse oximetry monitor unnecessary.
Seeking Alpha (5/16) 
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Biosense introduces CARTONET cardiac ablation data network
Johnson & Johnson division Biosense Webster has unveiled the CARTONET platform, a cloud-based network to enable health care providers and health systems to share and review data involving ablation procedures, including those from the company's CARTO 3 mapping system. The network will allow data to be accessed via laptops or tablets and will provide statistics through a clinical dashboard.
FierceBiotech (5/16) 
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Abiomed set to launch Impella CP with SmartAssist
Abiomed will release its Impella CP with SmartAssist at the Society for Cardiovascular Angiography & Interventions Scientific Sessions. The product comes with improvements to simplify patient management, integrate clinical data informatics and make the product easier to use.
MassDevice (Boston) (5/16) 
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Food and Drug Law Institute (FDLI) Highlights
Join Us this Summer | Medical Devices: FDA Regulation in the Era of Technology and Innovation | June 6, South San Francisco, CA
Join Us this Summer | Medical Devices: FDA Regulation in the Era of Technology and Innovation | June 6, South San Francisco, CA
The future is here! Our newly announced conference will cover the exciting promise of digital health and other medical device technology, FDA's recent regulatory initiatives, cybersecurity, artificial intelligence, and everything in between. View Agenda
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Fundamentals of Digital Health | June 5, South San Francisco, CA
Fundamentals of Digital Health | June 5, South San Francisco, CA
This California-based course will explore the essentials of FDA regulation of innovative medical device technologies, regulatory pathway options for getting a technologically-focused product on the market, and various digital health topics. Register Now
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