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Searching Content by Ropes & Gray LLP's FDA Regulatory Practice from Ropes & Gray LLP 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
FDA Issues Final Guidance On "Considerations In Demonstrating Interchangeability With A Reference Product"
On May 10, 2019, the Food and Drug Administration (FDA) issued final guidance on "Considerations in Demonstrating Interchangeability With a Reference Product," which describes the agency's
United States
6 Jun 2019
3
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
4
FDA Issues Final Guidance Documents Relating To Medical Product Manufacturer Communications
The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information.
United States
18 Jun 2018
5
FDA Issues Draft Guidance Regarding Waiver Of Single Shared System REMS Requirement
FDA Commissioner Scott Gottlieb has vowed to take steps to speed the review and approval of generic drugs as part of his overall priority to address concerns about drug prices.
United States
14 Jun 2018
6
FDA Issues Draft Guidance On Devices With Multiple Functions
On April 27, 2018, FDA issued draft guidance on the regulation of devices with multiple functions.
United States
15 May 2018
7
FDA User Fee Reauthorization Legislation Enacted By Congress
On July 12, 2017, the House of Representatives passed H.R. 2430, the FDA Reauthorization Act of 2017, and on August 3, 2017, the Senate followed suit by passing FDARA without amendment by a vote of 94-1.
United States
9 Aug 2017
8
FDA Announces New Digital Health Innovation Programs
As part of an overarching initiative to update its regulatory oversight of digital health technologies, the FDA has announced new plans to streamline the development and availability of high quality digital health products.
United States
31 Jul 2017
9
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
10
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
11
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
12
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
13
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
14
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
15
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
16
21st Century Cures Act – Provisions Relating To Development Incentives For Certain Classes Of Drugs
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
14 Dec 2016
17
FDA Holds Public Hearing On Manufacturer Communication Of Scientific And Medical Information
This Alert summarizes several key aspects of the hearing and describes its potential significance for regulated industry.
United States
15 Nov 2016
18
Podcast: FDA Holds Public Hearing On Manufacturer Communication Of Scientific And Medical Information
In this podcast, Doug Hallward-Driemeier moderates a discussion with partner Kellie Combs and senior counsel Alan Bennett about the FDA's open hearings regarding off-label communications.
United States
15 Nov 2016
19
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
20
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
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