Showing 21 - 40 of 90 search resultsTo further refine your results, please use quotation marks to search for an exact phrase (e.g. “class action”).
Feb
2
2017
Part II: The Impact of Cures on Clinical Research
… Part II: The Impact of Cures on Clinical Research Topics 21st Century Cures Act Webinar Series In addition to the myriad …
Medicaid Managed Care Rule Causes Concerns for Providers
… by July 2018. In 2016, Congress inserted a provision in the 21st Century Cures Act that mandated states implement Medicaid managed …
Jan
26
2017
Food, Drug & Cosmetic Law Section Meeting
… Device Hot Topics for 2017 Expected guidance documents, impact of 21 st Century Cures Act, update on FDA public hearings on off-label and …
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 …
May
11
2017
The NewYorkBIO 2017 Annual Conference
… The NewYorkBIO 2017 Annual Conference Topics Coordinating 21st Century Cures with The Trump Administration FDA Priorities The …
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 ). …
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 …
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 …
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 …
Mintz Attorneys and ML Strategies Professional to Speak at FDLI Programs
… Hawana will address how tools provided to FDA under the 21st Century Cures Act have been used by CBER to promote the development …
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 …