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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Ropes & Gray LLP's FDA Regulatory Practice ordered by Published Date Descending.
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FDA Issues Draft Guidance On Devices With Multiple Functions
On April 27, 2018, FDA issued draft guidance on the regulation of devices with multiple functions.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
2
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
3
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
4
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
5
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
6
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
7
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
8
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
9
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
10
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
11
The Cure For The Common FDA Reform Legislation? House Committee Releases 21st Century Cures Discussion Draft
On January 27, 2015, the House Energy & Commerce Committee ("E&C Committee") released a long-awaited discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative.
United States
3 Feb 2015
12
FDA Draft Guidance Clarifies Criteria And Process for Obtaining Rare Pediatric Disease Priority Review Vouchers
On November 17, 2014, the Food and Drug Administration ("FDA") released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to treat rare pediatric diseases.
United States
26 Nov 2014
13
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
14
FDA Approves Cancer Screening Test As First Device Under Parallel Review Pilot
Although begun in 2011 with much fanfare, and extended for an additional two years in December 2013, no devices had successfully navigated the process
United States
22 Aug 2014
15
FDA Releases Long-Awaited LDT Regulatory Framework And Finalizes Companion Diagnostics Guidance
The Food and Drug Administration took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices.
United States
11 Aug 2014
16
FDA Issues Final Guidance On Evaluating Substantial Equivalence In 510(K) Submissions
On July 28, 2014, the FDA issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications.
United States
7 Aug 2014
17
FDA Proposes Policy Change Concerning 5-Year NCE Exclusivity for Certain Fixed-Combination Drugs
Prompted by citizen petitions filed by Ropes & Gray and by two other companies, FDA issued draft guidance proposed a change in the Agency's interpretation of 5-year new chemical entity ("NCE") exclusivity as applied to certain fixed-combination drug products ("fixed-combinations").
United States
6 Mar 2014
18
FDA Issues Revised Draft Reprints Guidance
On February 28, 2014, the Food and Drug Administration ("FDA") released a revised draft guidance for industry entitled "Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices" ("Revised Reprints Guidance").
United States
5 Mar 2014
19
FDA Issues Draft Guidance Relating To Social Media Promotion By Drug And Biologics Manufacturers
On January 13, 2014, the Food and Drug Administration ("FDA") issued a draft guidance document outlining the circumstances under which a manufacturer of a prescription drug or biological product may be accountable for content conveyed through "interactive promotional media."
United States
15 Jan 2014
20
Key FDA Officials Signal Approach To Review Of Biosimilar Products - Agency Will Rely On A Risk-Based And "Totality Of The Evidence" Standard
In an article published in yesterday’s "New England Journal of Medicine ("NEJM")", several key officials with the Food and Drug Administration ("FDA") outlined an approach to review and approval of biosimilars in the United States.
United States
11 Aug 2011
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