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Research and Development › Proposed Rules

Levenfeld Pearlstein, LLC

So You Want to Keep That Patent? Well, It Just May Cost You — a Lot

Levenfeld Pearlstein, LLC on

U.S. patents are currently subject to maintenance fees paid to the U.S. Patent and Trademark Office (USPTO) at 3.5, 7.5, and 11.5 years from the date of grant to keep the patent live. The maintenance fees escalate over the...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Foley & Lardner LLP

ORI Proposes New Rulemaking for Research Misconduct Regulations

Foley & Lardner LLP on

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

Goodwin

Commerce Department Proposes New Export Controls On Gene-Editing Software That Will Also Expand The Scope Of Mandatory CFIUS...

Goodwin on

On Friday, November 6, 2020, the Commerce Department’s Bureau of Industry & Security (BIS) issued a Notice of Proposed Rulemaking (NPRM) seeking public comment regarding newly-proposed controls on certain software for...more

Bergeson & Campbell, P.C.

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

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

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

Morrison & Foerster LLP - Government...

Problems Abound with DOD’s Proposed IRAD Rule

Morrison & Foerster LLP - Government... on

On November 4, 2016, the Department of Defense proposed a new rule applicable to major defense contractors who expect to use future independent research and development (“IRAD”) to perform DoD contracts. The proposed rule...more

Pillsbury Winthrop Shaw Pittman LLP

Proposed Rule For Independent Research & Development (“IR&D”) Costs Raises Concerns

Pillsbury Winthrop Shaw Pittman LLP on

On November 4, 2016, the Department of Defense (“DOD”) issued a proposed rule that would amend the Defense Federal Acquisition Regulation Supplement (“DFARS”) to require DOD Contracting Officers to adjust offerors’ proposed...more

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