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GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

… subject the provision added the law December 2016 part the 21st Century Cures Act Specifically language added the Federal Food Drug …
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FDA Provides Update on Pre-Cert Program and Launches Digital Health Center of Excellence

… Center Excellence created January 2017 and authorized the 21st Century Cures Act Considering its organizational placement will …
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Cures Act Developments: FDA Publishes CFR Amendments Exempting Class II Devices with an Interesting Addition

Cures Act Developments FDA Publishes CFR Amendments … Exempting Class Devices with Interesting Addition Since the 21st Century Cures Act became law December 2016 have been keeping …
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FDA Updates Digital Health Guidances to Align with 21st Century Cures Act

… FDA Updates Digital Health Guidances Align with 21st Century Cures Act September 26 2019 FDA released suite revised …
Jan
12
2017
Event

Part I: Introduction to the 21st Century Cures Act

… Part Introduction the 21st Century Cures Act Topics 21st Century Cures Act Webinar Series This …
News

21st Century Cures Act & Real World Evidence: Device Policy as Foundation

21st Century Cures Act Real World Evidence Device Policy Foundation Bethany … and Benjamin Zegarelli coauthor this piece reviewing the 21st Century Cures Act that requires the Food Drug …
May
11
2017
Event

The NewYorkBIO 2017 Annual Conference

… The NewYorkBIO 2017 Annual Conference Topics Coordinating 21st Century Cures with The Trump Administration FDA Priorities The 21st
Feb
10
2017
Event

Trump's First 100 Days, Part IV: AMCs, Life Sciences, Pharma, and Medical Device Companies

… device companies among others Trump first 100 days the 21st Century Cures Act existing regulatory and research priorities and …
Feb
15
2018
Event

Part III: The Impact of Cures on the FDA

… Part III The Impact Cures the FDA Topics 21st Century Cures Act Webinar Series …
May
3
2019
Event

Food and Drug Law Institute Annual Conference

… Panel Description The tools provided FDA under the 21st Century Cures Act have been used CBER promote the development new …
Feb
2
2017
Event

Part II: The Impact of Cures on Clinical Research

… Part The Impact Cures Clinical Research Topics 21st Century Cures Act
Jan
18
2017
Event

Impact of the Cures Act on the Medical Device Industry

… Impact the Cures Act the Medical Device Industry MassMEDIC The 21st Century Cures Act significant bipartisan piece legislation …
Content

Mintz Attorneys and ML Strategies Professional to Speak at FDLI Programs

… Joanne Hawana will address how tools provided FDA under the 21st Century Cures Act have been used CBER promote the development new …
Case Study

Medicaid Managed Care Rule Causes Concerns for Providers

… providers July 2018 2016 Congress inserted provision the 21st Century Cures Act that mandated states implement Medicaid managed …
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Join Mintz and ML Strategies as We Kick-Off Our 21st Century Cures Act Webinar Series

… Join Mintz and Strategies KickOff Our 21st Century Cures Act Webinar Series Next Tuesday January 12th Mintz and …
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21st Century Cures Act – Med Tech Impact Webinar January 18

21st Century Cures Act Med Tech Impact Webinar January 18 you have seen our …
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Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities

… still working implement regulatory changes required the 21st Century Cures Act which was enacted December 2016 proposed rule …
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Regulators Look to Increase Interoperability and Patient Access to Health Data

… Information Technology ONC released proposed rule entitled 21st Century Cures Act Interoperability Information Blocking and the ONC …
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Strategies to Unlock AI's Potential in Health Care, Part 4: How and When Will Congress Act?

… role regulating the advancing field for example the 21st Century Cures Act which our colleagues previously discussed here The …
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ML Strategies Publishes Washington Outlook for 2016

… discussion number initiatives have been following 2015 21st Century Cures Act Senate Chronic Care Initiative Mental Health …