Category: FDA

March 4, 2016

More Information Available On Upcoming “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 final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the Regulatory System for Biotechnology Products." The memorandum, issued under the Executive Office of the President (EOP) and jointly by (OSTP), the Office of Management and Budget, the U.S. Trade Representative, and the Council on Environmental Quality, directs...
March 3, 2016

Agencies Convene Second Meeting On Modernizing Regulatory System For Biotechnology Products

On March 2, 2016, EPA and other federal agencies announced that the second public meeting on the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products" would be held March 9, 2016, in Dallas, Texas. 81 Fed. Reg. 10858. According to EPA, the March 9, 2016, meeting was convened to solicit comment on the current federal roles and responsibilities regarding biotechnology products. The July 2, 2015, memorandum was jointly issued by the Office of Science and...
February 29, 2016

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 now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. According to the U.S. Environmental Protection Agency (EPA),...
February 9, 2016

Oscar Hernandez, Former Head of EPA’s Office of Pollution Prevention and Toxics Risk Assessment Division, Joins Bergeson & Campbell, P.C. and The Acta Group

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Oscar Hernandez, Ph.D. has joined our teams as Senior Regulatory Chemist. Dr. Hernandez is the former Director of the Risk Assessment Division (RAD) in the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), where he managed a multi-disciplinary science group that provided expert scientific support in the areas of hazard and risk assessment of chemicals...
February 5, 2016

Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Organisms

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to "prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms." The notice identifies "reasonable...
February 5, 2016

Dates And Locations Of “Modernizing The Regulatory System For Biotechnology Products” Meetings Annou

On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on October 30, 2015, and a record of the meeting is available on the U.S. Food and Drug Administration (FDA) website. The second of the three meetings will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office in Dallas,...
February 5, 2016

Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Or

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to "prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms." The notice identifies...
February 3, 2016

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 "Modernizing the Regulatory System for Biotechnology Products."  The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas.  The third public meeting...
February 2, 2016

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 "Modernizing the Regulatory System for Biotechnology Products." The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas. The third public meeting will be held...
January 26, 2016

Susan M. Kirsch Joins Bergeson & Campbell, P.C. and The Acta Group as Government Affairs Advisor

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Susan M. Kirsch has joined our teams as Government Affairs Advisor. Ms. Kirsch brings substantial regulatory and technical policy expertise at the local, state, and federal levels, with experience at the New York State Department of Environmental Conservation, the U.S. Department of Justice, Environmental and Natural Resource Division, and most recently the Association of Clean Water...