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Searching Content indexed under Healthcare by Ropes & Gray LLP's FDA Regulatory Practice ordered by Published Date Descending.
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1
FDA CBD Roundup: Agency Continues Existing Enforcement Approach While Reviewing Public Comments And Considering Future Policy Approaches
On May 31, 2019, the U.S. Food and Drug Administration ("FDA") held a much-anticipated public hearing regarding "Scientific Data and Information
United States
12 Aug 2019
2
Aiming To Foster Innovation, FDA Proposes Regulatory Framework Specific To Prescription Drug Software
As such, the software output would be subject to FDA's regulations for FDA required labeling or promotional labeling, as applicable.
United States
5 Dec 2018
3
FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research
The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB's waiving or altering 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
26 Jul 2017
4
FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework
In his first public statement as Commissioner of the Food and Drug Administration ("FDA") on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes.
United States
26 Jun 2017
5
FDA Issues Three Key Documents Relating To Medical Product Manufacturer Communications
These documents represent a final attempt by the outgoing Administration to impact the agency's regulatory approach going forward.
United States
2 Feb 2017
6
FDA Finalizes Guidance On Postmarket Management Of Medical Device Cybersecurity
On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices.
United States
19 Jan 2017
7
21st Century Cures Act – Provisions To Promote Drug Development
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
8
21st Century Cures Act – Provisions Relating To Digital Health
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
9
21st Century Cures Act – Provisions Relating To Reimbursement & Fraud And Abuse
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate.
United States
15 Dec 2016
10
FDA Examining Role Of Hospitals In Medical Device Surveillance
On October 25, 2016, FDA announced an upcoming public workshop entitled, "The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance."
United States
29 Oct 2016
11
FDA Announces Public Hearing On Manufacturer Communications Regarding Off-Label Uses
On August 31, 2016, FDA announced that it will hold a two-day public hearing on November 9 and 10, 2016 to obtain input on issues related to manufacturer communications regarding drugs and medical devices.
United States
7 Sep 2016
12
FDA Issues Final Guidance on General Wellness Products
On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate "general wellness products," including software applications, ..
United States
4 Aug 2016
14
House Passes 21st Century Cures Act: What Does It Mean For Clinical Research?
On July 10, 2015, the U.S. House of Representative passed H.R. 6, the 21st Century Cures Act, with strong bipartisan support in a vote of 344-77.
United States
24 Jul 2015
15
Progressing Toward A Cure: House Committee Unveils Revised, Streamlined 21st Century Cures Discussion Draft
On April 29, 2015, the House Energy & Commerce Committee released a revised discussion draft of the medical innovation reform legislation that has been in the works for over a year as part of the 21st Century Cures Initiative.
United States
8 May 2015
16
FDA Issues Final Guidance Eliminating Regulatory Controls On Medical Device Data Systems, Imaging Storage Devices, And Imaging Communications Devices
The FDA intends not to enforce regulatory controls applicable to medical device data systems (MDDS), medical image storage devices, and medical image communication devices...
United States
12 Feb 2015
17
FDA Draft Guidances On General Wellness Products And Device Accessories Continue Risk-Based Approach To Health IT
Although not limited to the health IT sphere, both draft guidance documents address issues identified as requiring clarification in the April 2014 FDASIA Health IT Report.
United States
27 Jan 2015
18
FDA Final Guidance Confirms Role of Medical Device Firms in Cybersecurity Management
On October 2, 2014, the Food and Drug Administration ("FDA") released the final version of a guidance document entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
United States
3 Oct 2014
19
FDA, ONC, And FCC Issue Draft Report On The Regulation And Oversight Of Health IT Technologies
On April 3, 2014, the Food and Drug Administration ("FDA") released its long-awaited report on a proposed framework for the regulation and oversight of health information technology ("health IT").
United States
9 Apr 2014
20
FDA Alerts Medical Device Manufacturers And Hospitals To Cybersecurity Risks
The Food and Drug Administration recently issued an alert and draft guidance recommending that medical device manufacturers and health care facilities take measures to protect against cyberattacks that could compromise device performance and patient safety.
United States
21 Jun 2013
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