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Research and Development

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more

Bergeson & Campbell, P.C.

NRDC Challenges DOE Spending On Clean And Renewable Energy Initiatives

by Bergeson & Campbell, P.C. on

On December 10, 2018, the Natural Resources Defense Council (NRDC) submitted a letter urging Congress to investigate the reason for which DOE has not spent all of its 2018 fiscal year funding for clean energy research,...more

Bergeson & Campbell, P.C.

EPA Issues Proposed Rule to Harmonize EPA-specific Regulations in Revised Common Rule

by Bergeson & Campbell, P.C. on

On December 6, 2018, the U.S. Environmental Protection Agency (EPA) announced it was proposing a rule (83 Fed. Reg. 62760) to harmonize the EPA-specific regulations regarding research involving human subjects conducted or...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

by Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

Hogan Lovells

Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support...

by Hogan Lovells on

On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage information gathered from real-world data (RWD): data that relates to patient...more

Hogan Lovells

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

by Hogan Lovells on

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

Bergeson & Campbell, P.C.

DOE ARPA-E OPEN 2018 Program Announces Funding For New Projects

by Bergeson & Campbell, P.C. on

On November 15, 2018, the U.S. Department of Energy’s (DOE) Advanced Research Projects Agency-Energy (ARPA-E) announced the latest open funding opportunity for 40 new projects (OPEN 2018). The funds add up to $98 million and...more

Dentons

DOD Quietly Kills Another Controversial IR&D Rule

by Dentons on

On November 4, 2016, the Department of Defense (“DOD”) published a proposed change to the Department of Defense Federal Acquisition Regulation Supplement (“DFARS”) that would have significantly altered DOD’s regulatory...more

Foley & Lardner LLP

That ‘Hot’ Research Project May Land Your Lab in Hot Water

by Foley & Lardner LLP on

Most busy scientific research laboratories have a spectrum of projects underway at any given time. Some projects are producing exciting results, and others seem to be heading nowhere. Why not shift personnel from the losers...more

White & Case LLP

A brief overview of the Code of the Republic of Kazakhstan "On subsoil and subsoil use"

by White & Case LLP on

As it is known, the Code of the Republic Kazakhstan "On subsoil and subsoil use," which was adopted 27 December 2017 (the "SSU Code"), came into force on 29 June of this year....more

K&L Gates LLP

OHRP Provides Draft Guidance Regarding the Common Rule’s Public Health Surveillance Exclusion

by K&L Gates LLP on

On November 19, 2018, the U.S. Department of Health and Human Services, Office for Human Research Protections (“OHRP”) announced the availability of additional draft guidance related to a new exclusion from regulatory...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Arkansas Bulletin of Water Research: Arkansas Water Resources Center Publishes 2018 Issue

The 2018 issue of the Arkansas Bulletin of Water Research (“Bulletin”) has been published. The Bulletin is published annually by the Arkansas Water Resources Center (“AWRC”). AWRC is a component of the University of...more

Dechert LLP

New Government Regulation of Emerging Technology

by Dechert LLP on

The U.S. Government has instituted a major new initiative to regulate emerging technology, potentially including artificial intelligence, biotechnology, robotics, data analytics and many other types of emerging technology,...more

Bergeson & Campbell, P.C.

DOE Announces Phase II Topics For FY 2019

by Bergeson & Campbell, P.C. on

On November 13, 2018, the U.S. Department of Energy (DOE) announced the topic areas for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) for research and development (R&D) proposals for...more

Dentons

Navigating continuous disclosure in the life sciences sector

by Dentons on

Continuous disclosure obligations cause difficulties for many listed organisations. These difficulties are further amplified in the life sciences sector where entities need to communicate complex scientific information to...more

Holland & Knight LLP

Left to Their Own Devices: Administration, FDA Turn to Medical Device Innovation

by Holland & Knight LLP on

• Masked by the recent high-profile drug pricing debate has been the Trump Administration's discussions about the development, approval and reimbursement of medical devices. Recent comments by Administration leaders, as well...more

Thompson Coburn LLP

Missouri’s 2018 medical cannabis initiatives: Part 1 – The basics

by Thompson Coburn LLP on

Three initiatives on Missouri’s November 6, 2018, ballot seek to make medical marijuana or medical cannabis legal under Missouri state law. This series of posts describes the similarities and differences among the...more

Bergeson & Campbell, P.C.

EC Announces BioWatch

by Bergeson & Campbell, P.C. on

The European Commission (EC) announced on October 16, 2018, the launch of a new web-based tool called BioWatch. Developed by BIOWAYS, a project funded by the European Union (EU), this new tool expands BIOWAYS’ efforts in...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Strengthening the Integration of Solar on the Electricity Grid: U.S. Department of Energy Announces Availability of $46 Million in...

The United States Department of Energy (“DOE”) announced in an October 15th news release the availability of up to $46 million in research funding to: . . . advance holistic solutions that provide grid operators the...more

Akin Gump Strauss Hauer & Feld LLP

False Claims Act Suit Dismissed Based on Granston Memo Considerations

• DOJ is implementing the Granston memo policy in seeking dismissal of FCA qui tam actions when it is in the government’s interest, particularly when protecting its resources, discretion and litigation priorities. • DOJ...more

White & Case LLP

Energy storage: Opportunities, key trends and market drivers

by White & Case LLP on

Deployment of battery storage technology is gaining pace, but it may struggle to reach its full potential until energy regulation and financing solutions adapt. Battery storage has traditionally been seen as a supplement...more

Holland & Knight LLP

Granston Memo in Action: DOJ Successfully Exercises Authority to Dismiss Meritless Qui Tam

by Holland & Knight LLP on

A recent dismissal of a qui tam action demonstrates there exists an affirmative approach for disposing of wasteful and meritless non-intervened qui tam claims without the time and expense of protracted litigation with...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Distributed Ledger: Blockchain, Digital Assets and Smart Contracts

This is the inaugural issue of The Distributed Ledger, a periodic publication covering the latest trends and developments in blockchain technology, digital assets and smart contracts. In this edition, we examine a federal...more

Shearman & Sterling LLP

IRS Announces Study of Active Trade or Business Requirement for Spin-off Transactions

by Shearman & Sterling LLP on

On September 25, 2018, the IRS announced that it is undertaking a study regarding the application of the five-year active trade or business requirement of Section 355(b) (the “ATB Requirement”) to entrepreneurial ventures...more

Akin Gump Strauss Hauer & Feld LLP

Policymakers Focusing in on Artificial Intelligence

Following a series of recent events involving policymakers from Trump’s Administration and Capitol Hill, artificial intelligence (AI) was the second hottest topic in D.C. These events, described in detail below, demonstrated...more

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Updated: May 25, 2018:

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Links to Other Websites

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Information for EU and Swiss Residents

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Changes in Our Privacy Policy

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Contacting JD Supra

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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