Searching Content indexed under Healthcare by Gregory Levine ordered by Published Date Descending.
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Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb's Unfinished Business
Tune in to this discussion to learn more about the unfinished business of the Gottlieb administration, the impact of his resignation, and how the agency will move forward under Acting Commissioner Ned Sharpless.
United States
8 May 2019
The Latest FDA Move To Limit Digital Health Software Regs
The FDA also announced a Jan. 30, 2018, public workshop on the progress of the Software Precertification Pilot Program.
United States
28 Dec 2017
A Modern Approach To Digital Health Product Regulation
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has announced new plans to streamline the development...
United States
9 Aug 2017
Outlook 2017 Teleconference: Revisiting the Trump Administration's Impact on Life Sciences and Health Care—the First 100 Days
On Tuesday, May 2, Ropes & Gray hosted a teleconference, "Outlook 2017 Teleconference: Revisiting the Trump Administration's Impact on Life Sciences and Health Care – the First 100 Days," on the potential regulatory and compliance impact of the Trump Administration on life sciences and health care companies.
United States
24 May 2017
FDA Indefinitely Delays Action On Regulating Laboratory Developed Tests
On November 18, 2016, the Food and Drug Administration (FDA) notified industry groups that it no longer plans to finalize its draft guidance on laboratory developed tests (LDTs).
United States
24 Nov 2016
Digital Health Pulse: Regulatory And Transactional Developments
I'm Greg Levine, a partner in the life sciences practices at Ropes & Gray.
United States
17 Aug 2016
FDA Issues Draft Guidance Eliminating Regulatory Controls On Medical Device Data Systems, Imaging Storage Devices, And Imaging Communications Devices
The FDA issued a draft guidance document announcing that the agency does not intend to enforce the general regulatory controls applicable to medical device data systems.
United States
30 Jun 2014
The Federal Payment Sunshine Law
On January 1, 2012, manufacturers of drugs, biologics, devices and medical supplies covered under Medicare, Medicaid and the Children’s Health Insurance Program.
United States
30 Sep 2011
FDA Issues Final Rule On Medical Device Data Systems
On February 15, 2011, the United States Food and Drug Administration (FDA) issued a final rule formally "reclassifying" Medical Device Data Systems (MDDSs) from Class III into Class I.
United States
23 Feb 2011
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