B&C News: FDA

June 19, 2019
FDA FSMA Food Defense Plan Requirements
  Wednesday, July 24, 2019 1:00 p.m. - 2:00 p.m. (EDT)   Register for this complimentary webinar 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 ... 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Bloomberg BNA Daily Environment Report Includes Comments by Lynn L. Bergeson Regarding FDA Draft Guidance for Nanomaterial Drugs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so small they can't be seen with a regular microscope—got some advice on how to assess their risks in FDA draft guidance issued Dec. 15.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 >
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