B&C News: FDA

April 14, 2020
COVID-19, FIFRA, and EPA -- A Conversation with Lisa Campbell
Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, COVID-19, FIFRA, and EPA -- A Conversation with Lisa Campbell.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Lisa M. Campbell, one of the nation’s foremost legal experts on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a Partner at B&C, sat down to discuss U.S. Environmental Protection Agency (EPA) approval of products under FIFRA to combat COVID-19, the disease caused by the coronavirus.   Since the start ... read more >
January 15, 2020
Bergeson & Campbell’s Forecast 2020
This week, I sat down with my colleagues Sheryl Lindros Dolan, Chris Bryant, and Dr. Richard Engler to discuss our fabulous 2020 Forecast, B&C’s and The Acta Group’s (Acta®) richly detailed overview of key trends in U.S. and global chemical law and policy. This 67-page document provides a comprehensive “one-stop” overview of global initiatives for the New Year of which stakeholders in the global chemical market must be aware. My colleagues provide a spirited overview of key developments, speculate on the impact of the U.S. general elections later this year, ... read more >
July 11, 2019
REGISTER NOW—FDA FSMA Food Defense Plan Requirements Webinar
Register Now FDA FSMA Food Defense Plan Requirements Wednesday, July 24, 2019 1:00 p.m. - 2:00 p.m. (EDT)   Overview:   The U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) is the most comprehensive reform measure created to prevent food-borne illness.  Enacted in 2011, FSMA includes massive legislative changes aimed to prevent food-borne diseases.  One of the FSMA foundational rules, Mitigation Strategies to Protect against Intentional Adulteration, requires non-exempt entities to develop the appropriate preventive measures by July ... read more >
June 19, 2019
FDA FSMA Food Defense Plan Requirements
  Wednesday, July 24, 2019 1:00 p.m. - 2:00 p.m. (EDT)   View this webinar on demand online. Overview:   The U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) is the most comprehensive reform measure created to prevent food-borne illness.  Enacted in 2011, FSMA includes massive legislative changes aimed to prevent food-borne diseases.  One of the FSMA foundational rules, Mitigation Strategies to Protect against Intentional Adulteration, requires non-exempt entities to develop the appropriate preventive measures by July 26, ... read more >
May 22, 2019
Preserving Cosmetics on a Global Scale:  It is Harder than You Think
Preserving Cosmetics on a Global Scale: It is Harder than You Think Wednesday, May 22, 2019 1:00 p.m. - 2:00 p.m. (EDT) Register Today Overview: Cosmetic formulations often contain preservatives to protect the product’s integrity and extend its shelf life. The regulatory requirements that product manufacturers must adhere to when incorporating preservatives into their products and what claims are permissible on their product labels is far from harmonized globally, and the path is not getting easier. This webinar will provide an overview of cosmetic ingredient regulations in the ... read more >
October 19, 2018
B&C Presents “Keeping up with FSMA – Rules, Obligations, and Key Compliance Dates” Webinar
On October 17, 2018, Bergeson & Campbell, P.C. (B&C®) presented a complimentary webinar regarding pending implementation dates of key U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) rules. “Keeping up with FSMA – Rules, Obligations, and Key Compliance Dates” was presented by Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, Lynn L. Bergeson, Managing Partner, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, and showed registrants how to prepare for forthcoming deadlines and how the intended use of a ... read more >
September 21, 2018
Keeping up with FSMA—Rules, Obligations, and Key Compliance Dates
  Wednesday, October 17, 2018 1:00 p.m. - 2:00 p.m. (EDT)  Complimentary Registration Available Online   Speakers: ■  Karin F. Baron, MSPH Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®)   ■  Lynn L. Bergeson Managing Partner, B&C; President, Acta   ■  Scott J. Burya, Ph.D. Regulatory Chemist, B&C and Acta   With key implementation dates of several core elements of the U.S. Food and Drug ... read more >
December 18, 2017
Bloomberg BNA Daily Environment Report Includes Comments by Lynn L. Bergeson Regarding FDA Draft Guidance for Nanomaterial Drugs
On December 18, 2017, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), was quoted by the Bloomberg BNA Daily Environment Report in the article “FDA Pushes Risk-Based Approach to Nanomaterial Drugs.” Developers of drugs containing nanomaterials—substances so small they can't be seen with a regular microscope—got some advice on how to assess their risks in FDA draft guidance issued Dec. 15. […] Without having read it in detail yet, Lynn Bergeson, managing partner of Bergeson & Campbell PC, told Bloomberg BNA in a Nov. ... read more >
October 6, 2017
Inside EPA Quotes B&C Memorandum on EPA, FDA Jurisdiction for Mosquito Related Products
On October 6, 2017, Inside EPA quoted a recent Bergeson & Campbell, P.C. (B&C®) memorandum in the article “EPA wins power to oversee biotech mosquito controls.” EPA and the Food and Drug Administration (FDA) have issued new guidance clarifying that EPA has authority for regulating biotechnology (Bt) products such as genetically modified mosquitoes that are used to control the pests, a step that one industry law firm says will be helpful for navigating a federal “jurisdictional quagmire." […] In an Oct. 5 blog, the law firm Bergeson and Campbell ... read more >
June 2, 2016
Lynn L. Bergeson Presents “The Nanotechnology Legal and Regulatory Landscape” at the 2016 International Nanotoxicology Congress
On June 2, 2016, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), presented “The Nanotechnology Legal and Regulatory Landscape” at the 2016 International Nanotoxicology Congress in Boston. Ms. Bergeson stated that there are many ongoing global initiatives involving diverse governance aspects of nanoscale materials and many countries continue to make progress in defining nanoscale materials, addressing related definitional challenges, developing suitable governance approaches to manage potential risks, and conducting testing while developing ... read more >
April 13, 2015
Stewardship 2015 Presents Vital Program for Product Stewardship Professionals
Lynn L. Bergeson Joins Product Stewardship Society Board of Directors Stewardship 2015, June 1-3, 2015, Salt Lake City, Utah, is the only national conference dedicated to educating and equipping product stewards, industrial hygienists, environmental health and safety (EHS) professionals, and others involved in the day-to-day work of product stewardship. Stewardship 2015 is co-located with AIHce2015, the premiere conference and exposition for occupational and EHS professionals. Stewardship 2015 is presented by the Product Stewardship Society, a membership organization ... read more >
January 12, 2015
Jane Vergnes, Ph. D., Quoted in Bloomberg BNA Daily Environment Report Article "FDA Says More Data Needed to Determine If Six Chemicals Safe for Use in Sunscreens"
Comments made by Jane S. Vergnes, Ph.D., were featured in a Bloomberg BNA Daily Environment Report article covering the initial determination by the U.S. Food and Drug Administration that additional data are needed to establish that six chemicals submitted for inclusion as active ingredients in the over-the-counter sunscreen monograph using the Time and Extent Application processes are generally recognized as safe and effective.   The decisions show the bar to get new active ingredients into sunscreens remains high in the U.S., Jane Vergnes, a toxicologist working with ... read more >
June 27, 2014
Lynn L. Bergeson focus of Bloomberg BNA Daily Environment Report story "FDA Oversight May Be Required for New, Altered Chemicals, Products, Attorney Says."
Bloomberg BNA Daily Environment Report reported on Lynn L. Bergeson’s comments regarding final nanotechnology guidances released by the Food and Drug Administration. “The guidances reaffirm the FDA’s position that it has sufficient statutory authorities and policies to oversee the safety of products it regulates, Bergeson said. She expanded on that perspective in a memo her law firm issued. The FDA also restated its view that nanotechnology isn’t inherently safe or harmful, but that specific characteristics of individual products determine safety or harmfulness, ... read more >
April 6, 2012
Toxic Tort Lawsuits Seen as Less Likely in Wake of FDA Decision on Bisphenol A
The April 6, 2012, issue of Bloomberg BNA Daily Environment Report quotes Lynn L. Bergeson regarding the Food and Drug Administration’s (FDA) recent decision to reject the Natural Resources Defense Council’s petition to ban the use of bisphenol A in food ... read more >
June 27, 2011
Groups Criticize FDA Sunscreen Rules For Not Addressing Nanoscale Ingredients
The June 27, 2011, issue of BNA Daily Environment Report quotes Lynn L. Bergeson regarding the Food and Drug Administration's (FDA) response to the International Center for Technology Assessment's (ICTA) petition concerning nanoscale ingredients in ... read more >
March 24, 2011
Jayne Bultena Joins Bergeson & Campbell, P.C. and Brings Valuable Experience to Its FDA Practice
Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that Jayne Bultena has joined B&C as Of Counsel. Ms. Bultena brings a distinguished background on a wide range of matters arising under the Federal Food, Drug, and Cosmetic Act. She has represented Fortune 100 companies, start-ups, and venture capital investors on several issues, including developing and implementing life-cycle management strategies using patent and non-patent (Hatch-Waxman) options, including ... read more >

 
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