Searching Content indexed under Food and Drugs Law by Gregory Levine ordered by Published Date Descending.
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Podcast: Non-binding Guidance: Expedited Review Programs For Drugs And Biologics
Tune in to this discussion to learn more about the expedited review programs and how to secure the benefits.
United States
10 Sep 2019
A Guide To FCA Cooperation Credit For Life Sciences Companies
On May 7, 2019, the U.S. Department of Justice issued guidelines describing when and under what circumstances it will award cooperation credit in False Claims Act matters.
United States
9 Jul 2019
Podcast: Non-Binding Guidance: Examining FDA's Enforcement Authority Over Stem Cell Clinics And Compounders
The third installment of Ropes & Gray's podcast series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas.
United States
4 Jul 2019
New FDA Draft Guidance On Voluntary Recalls Asks: Are You Prepared?
On April 24, 2019, the Food and Drug Administration ("FDA") released a draft guidance, entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,"
United States
21 May 2019
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
FDA Clarifies Communication Rules For Medical Product Companies
On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling.
United States
25 Jun 2018
Lessons From FDA Draft Guidance On Multifunctional Devices
On April 27, 2018, the U.S. Food and Drug Administration issued draft guidance on the regulation of devices with multiple functions.
United States
25 May 2018
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
What To Know About New FDA Informed Consent Guidance
On July 25, 2017, the U.S. Food and Drug Administration issued a guidance document1 announcing its intention not to object to an institutional review board's (IRB) waiving or altering of the informed consent requirements for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections.
United States
15 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
Federal Sunshine Law: Proposed Rule And Implementation Delay
On December 14, 2011, the Centers for Medicare & Medicaid Services (CMS) released long-awaited guidance on the implementation of the Federal Sunshine Law (42 U.S.C. 1320a-7h) in the form of a proposed rule.
United States
30 Dec 2011
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