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Biotechnology Public Comment

Goodwin

Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Implications for...

Goodwin on

On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...more

Goodwin

CMS Issues First Request for Public Comments on the Medicare Drug Price Negotiation Program “Small Biotech” Exception - Due March...

Goodwin on

The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more

Hogan Lovells

FDA invites comments on xenotransplantation product regulatory standards ahead of public meeting

Hogan Lovells on

On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss its regulatory expectations for...more

Bergeson & Campbell, P.C.

APHIS Announces Draft Regulatory Status Review Guide Available for Public Comment

On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...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

Wiley Rein LLP

Recent Actions on Ag Biotech by EPA’s Emerging Technologies Branch

Wiley Rein LLP on

In this webinar, Keith Matthews from Wiley's Environment & Product Regulation group discusses recent actions by the U.S. Environmental Protection Agency (EPA) Biopesticides and Pollution Prevention Division's (BPPD) Emerging...more

Wiley Rein LLP

Five Key Takeaways From EPA’s Biotech PIPs Exemption Proposed Rule

Wiley Rein LLP on

On October 9, the U.S. Environmental Protection Agency (EPA) published for public comment its long-awaited proposed rule to exempt from most requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)...more

Jones Day

Artificial Intelligence and the Biopharmaceutical Industry: What's Next?

Jones Day on

The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...more

Hogan Lovells

Proposed additions of chemical families to Schedule 1 of Chemical Weapons Convention and BIS requests for comments from chemical,...

Hogan Lovells on

On 14 August 2019 the U.S. Department of Commerce published a proposed change to the list of "Schedule 1" chemicals in the "Annex on Chemicals" to the Chemical Weapons Convention (CWC). ...more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

Holland & Knight LLP on

Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

Skadden, Arps, Slate, Meagher & Flom LLP

US Department of Commerce Solicits Comments Regarding Emerging Technologies That Are Essential to US National Security

On November 19, 2018, the Bureau of Industry and Security, U.S. Department of Commerce (BIS) published an advance notice of proposed rulemaking (ANPRM) soliciting comments on the criteria to be used to identify emerging...more

Dechert LLP

New Government Regulation of Emerging Technology

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.

USDA Seeks Public Comment On Collection Of Biobased Procurement Data

On March 12, 2018, the U.S. Department of Agriculture (USDA) issued in the Federal Register a notice announcing the submission of an information collection request (ICR) on the guidelines for designating biobased products for...more

Bergeson & Campbell, P.C.

Agencies Seek Public Comment On Extension Of ICR On Biobased Procurements Data

On December 4, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public...more

Bergeson & Campbell, P.C.

FDA, USDA, and EPA to Hold Public Sessions on Agricultural Biotechnology

On October 25, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced that the U.S. Food and Drug Administration (FDA), in coordination with the U.S. Department of Agriculture’s...more

Bergeson & Campbell, P.C.

Agencies Request Public Comment On Collection Of Biobased Procurements Data

On August 28, 2017, the U.S. Department of Defense (DOD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) issued in the Federal Register a notice of request for public...more

Bergeson & Campbell, P.C.

USDA Extends Comment Period On Biobased Product Categories For Federal Procurement

On February 21, 2017, USDA announced in the Federal Register that the comment period for the Designation of Product Categories for Federal Procurement proposed rule had been extended. The proposed rule aims to amend the...more

Bergeson & Campbell, P.C.

Comment Deadline Approaches On Update To The Coordinated Framework For The Regulation Of Biotechnology

As previously reported in the Biobased and Renewable Products Advocacy Group’s (BRAG®) Biobased and Renewable Products Update of September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated...more

Bergeson & Campbell, P.C.

Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Reg

On September 22, 2016, Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the Federal Register ....more

Beveridge & Diamond PC

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

Beveridge & Diamond PC on

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more

Mintz - Consumer Product Safety Viewpoints

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to...more

Bergeson & Campbell, P.C.

EPA Announces Public Meeting On Algae And TSCA

On September 1, 2016, the Algae Biomass Organization (ABO) announced that the U.S. Environmental Protection Agency (EPA) will be hosting an "Opportunity for Public Comment on Algae Guidance for The Preparation of [Toxic...more

Bergeson & Campbell, P.C.

National Academies Of Sciences, Engineering, And Medicine Holding Second Public Meeting On Future

The National Academies of Sciences, Engineering, and Medicine is hosting a second public meeting examining future biotechnology products on June 1-2, 2016. This two-day meeting will run from 9:00 a.m. - 5:30 p.m. both days,...more

Bergeson & Campbell, P.C.

Advisory Committee On Biotechnology And 21st Century Agriculture To Meet

On November 19, 2015, the USDA published Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational...more

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