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OSTP Food and Drug Administration (FDA)

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2024

TSCA/FIFRA/TRI - White House OSTP Releases PFAS Federal R&D Strategic Plan:The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - June 2024

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

Bergeson & Campbell, P.C.

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, December 2023

TSCA/FIFRA/TRI - U.S. Tire Manufacturers Association And USGS Partner For Joint Research Into 6PPD Alternatives: On November 15, 2023, the U.S. Tire Manufacturers Association (USTMA) announced that it will partner with the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 10. In This Month’s E-News: October 2022

Report on Research Compliance 19, no. 10 (October, 2022) - Beginning Oct. 1, Renee Wegrzyn will be the first permanent director of the Advanced Research Projects Agency for Health (ARPA-H), the new HHS agency modeled...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Sheppard Mullin Richter & Hampton LLP

Trade Secret Protection & the COVID-19 Cure: Observations on Federal Policy-Making & Potential Impact on Biomedical Advances

As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2017

TSCA/FIFRA/TRI - EPA Schedules PPDC Meeting: On October 13, 2017, the U.S. Environmental Protection Agency (EPA) announced the scheduling of a Pesticide Program Dialogue Committee (PPDC) meeting for November 1-2, 2017. 82...more

Bergeson & Campbell, P.C.

NAS Issues Report on Preparing for Future Products of Biotechnology

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report: Preparing for Future Products of Biotechnology. Pursuant to the White...more

Bergeson & Campbell, P.C.

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and...more

Bergeson & Campbell, P.C.

Biotechnology: White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the...

On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology," releasing two documents intended to modernize federal regulation of biotechnology...more

Bergeson & Campbell, P.C.

EPA, FDA, and USDA Release Updates to Coordinated Framework on Biotechnology

On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, August 2016

TSCA/FIFRA/IRIS/NTP/TRI - EPA Releases TRI Preliminary Dataset For Calendar Year 2015: On July 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the availability of the Toxics Release Inventory (TRI)...more

Bergeson & Campbell, P.C.

NAS Releases Agenda for First Future Biotechnology Products and Regulatory System Committee Meeting

On April 5, 2016, the National Academies of Science, Engineering, and Medicine (NAS) posted the Agenda for the first open session of its committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of...more

Bergeson & Campbell, P.C.

Sign Up For The Third And Final Public Meeting On Modernizing The Regulatory System For Biotechnology Products

On July 2, 2015, the Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality jointly issued Modernizing the Regulatory...more

Bergeson & Campbell, P.C.

Biotechnology: Academies to Study Future Products of Biotechnology

On March 18, 2016, the National Academies of Science, Engineering, and Medicine (The Academies) announced the appointment of its provisional committee on "Future Biotechnology Products and Opportunities to Enhance...more

Bergeson & Campbell, P.C.

Biotechnology: Case Studies of Hypothetical, Genetically Engineered Organisms Are Discussed at Second Meeting on Modernizing the...

On March 9, 2016, the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products,” was convened in the U.S. Environmental Protection Agency’s (EPA) Region 6...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2016

TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk...more

Bergeson & Campbell, P.C.

More Information Available On Upcoming "Modernizing The Regulatory System For Biotechnology Products" Meetings

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the...more

Bergeson & Campbell, P.C.

Biotechnology: Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9

The second public meeting on the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products" will be held March 9, 2016, from 9:30 a.m. to 1:00 p.m. (CT) in Dallas, Texas. Registration is...more

Mintz - Consumer Product Safety Viewpoints

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two...more

Bergeson & Campbell, P.C.

OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled...more

Bergeson & Campbell, P.C.

Public Meeting Announced To Discuss Modernizing the Regulatory System For Biotechnology Products Memorandum

On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA)...more

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