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Biotechnology › Comment Period

Bergeson & Campbell, P.C.

EC Publishes Summary Report on Public Consultation for EU Bioeconomy Strategy

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The European Commission (EC) has published a report summarizing comments received during the public consultation for the initiative “Towards a circular, regenerative and competitive bioeconomy.” As reported in our April 1,...more

Morrison & Foerster LLP

Comment on Morphing U.S. Biotechnology Regulations

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The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more

Akin Gump Strauss Hauer & Feld LLP

US Seeks Comments on Text for WIPO Genetic Resources Treaty

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Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more

Goodwin

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

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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

Bergeson & Campbell, P.C.

OSTP Publishes RFIs on Coordinated Framework for the Regulation of Biotechnology and National Biotechnology and Biomanufacturing...

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As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology...more

Hogan Lovells

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

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On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more

Bergeson & Campbell, P.C.

APHIS Announces Draft Regulatory Status Review Guide Available for Public Comment

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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

Goodwin

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

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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

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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

Bergeson & Campbell, P.C.

OSTP Requests Information On The U.S. Bioeconomy

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On September 10, 2019, the U.S. Office of Science and Technology Policy (OSTP) announced in the Federal Register a request for information (RFI) on the U.S. bioeconomy....more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

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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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | November 2018

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LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Plan to “Advance Plant, Animal Biotechnology Innovation” - U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued a statement announcing the...more

K&L Gates LLP

FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative

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On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and request for comments related to the initial phase of the Agency’s...more

Hogan Lovells

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump's Regulatory Reform Executive Orders

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Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more

Goodwin

FDA Requests Comment on Term “Natural” in Food Labeling

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On November 10, 2015, the FDA announced that it will be soliciting public comments on the use of the term “natural” in food labeling. The comment period will open on November 12, 2015 and is expected to close on February 10,...more

Bergeson & Campbell, P.C.

Biotechnology: OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the...

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On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of...more

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