| Mintz

Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?

… Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA? On Wednesday, the U.S. …

President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

… President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative …

Cures Act Developments: FDA Proposes Class II Device Exemptions

… Cures Act Developments: FDA Proposes Class II Device Exemptions Since the 21st Century Cures Act became law on December 13, 2016, we have …

Feb

10

2017

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

… companies, among others. In Trump's first 100 days, the 21st Century Cures Act, existing regulatory and research priorities, and …

Feb

15

2018

Part III: The Impact of Cures on the FDA

… Part III: The Impact of Cures on the FDA Topics 21st Century Cures Act Webinar …

Regulators Look to Increase Interoperability and Patient Access to Health Data

… Technology (ONC) released a proposed rule entitled 21st Century Cures Act: Interoperability, Information Blocking, and the …

Strategies to Unlock AI's Potential in Health Care, Part 4: How and When Will Congress Act?

… role in regulating the advancing field; for example, the 21st Century Cures Act (which our colleagues previously discussed here ). …

May

3

2019

Food and Drug Law Institute Annual Conference

… DC. Panel Description: The tools provided to FDA under the 21st Century Cures Act have been used by CBER to promote the development …

Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities

… working to implement regulatory changes required by the 21st Century Cures Act, which was enacted in December 2016. A proposed …

Jan

18

2017

Impact of the Cures Act on the Medical Device Industry

… Impact of the Cures Act on the Medical Device Industry MassMEDIC The 21st Century Cures Act is a significant bipartisan piece of …

Senate HELP Committee Convenes Third and Final Cures Markup

… Senate HELP Committee Convenes Third and Final Cures Markup This morning the Senate Committee on Health, … package. This package is a compliment to the House-passed 21st Century Cures Act, which the House passed in July of 2015. …

Health Care Update & Telehealth Policy Alert

… the Medicare program to providers of telehealth services. 21st Century Cures Initiative: On the House side, the Energy and Commerce …

FDA Introducing a Variety of Programs to Help Medical Devices Get to Market

… visible, such as the Breakthrough Devices program in the 21st Century Cures Act and the Software Precertification pilot program in …

ML Strategies Publishes Washington Outlook for 2016

… on a number of initiatives we have been following in 2015: 21st Century Cures Act Senate Chronic Care Initiative Mental Health …

This Week’s ML Strategies Health Care Update: Big Changes (Possibly) Ahead for Drug Manufacturers

… also expressed interest in this issue when it passed the 21st Century Cures Act. The Amarin Pharma decision is another significant …

Health Care Congressional Outlook for the June Work Period

… bills, and work on that is expected to resume this week. 21st Century Cures The Senate’s version of the 21st Century Cures Act has …

ML Strategies Health Care Congressional Outlook

… this summer. The Senate continues its work on the 21 st Century Cures Act , but funding issues continue to hamper progress. … preview, please click here . June 08, 2016 Blog Health Care 21st Century Cures Health Care Congressional Outlook mental …

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