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Bergeson & Campbell, P.C.

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

TSCA/FIFRA/TRI - EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk To Human Health: On April 16, 2024, the U.S. Environmental Protection Agency (EPA) announced...more

Ankura

Is Your DNA Safe? DNA Sequencing Machines Found to Contain Critical Vulnerabilities

Ankura on

Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...more

King & Spalding

Dismissal of Securities Claims Against Utah Biotech Company Provides Guidance in Securities Cases Involving Food & Drug...

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A district court in Utah recently dismissed claims brought against a biotechnology company and its officers under Section 10(b) of the Securities Exchange Act and Rule 10b-5 adopted thereunder. The order in Richfield v....more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2022

TSCA/FIFRA/TRI - ARTICLE -- Lynn L. Bergeson And Richard E. Engler, Ph.D. Author “Optimizing The Toxic Substances Control Act To Achieve Greener Chemicals,” For ABA’s NR&E Magazine: TSCA offers tremendous unrealized...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, February 2021

TSCA/FIFRA/TRI - “Environmental Justice: Operationalizing TSCA to Fulfill Its Destiny,” By Lynn L. Bergeson For The American College Of Environmental Lawyers (ACOEL) Blog: The Biden Administration has embraced environmental...more

Patterson Belknap Webb & Tyler LLP

The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated #2)

September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca. In line with FDA’s June 2020...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2020

TSCA/FIFRA/TRI - Lynn L. Bergeson, “Feeling The Pinch: Who Pays TSCA Risk Evaluation Fees?,” Financier Worldwide, September 2020: Ordinarily, government fees command little interest in corporate finance and board-level...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2019

TSCA/FIFRA/TRI - EPA Seeks Comment On Manufacturer Requests For Risk Evaluation Of DIDP And DINP: On August 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it seeks comment on manufacturer requests...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more

Skadden, Arps, Slate, Meagher & Flom LLP

HKEx Reforms Attract High-Profile Technology and Biotech Listings

In the past year, nearly a dozen companies have taken advantage of new rules to list on the Stock Exchange of Hong Kong Limited (HKEx). On April 30, 2018, HKEx introduced a series of reforms to encourage the listing of...more

Fox Rothschild LLP

Animal Biotechnology-The Way Forward

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On October 30, 2018, the U.S. Food and Drug Administration “announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, April 2019

TSCA/FIFRA/TRI - EPA Releases Budget Justification That Increases Budget For Chemical Risk, Review, And Reduction Program: On March 11, 2019, EPA released its Fiscal Year (FY) 2020 Justification of Appropriation Estimates...more

Wilson Sonsini Goodrich & Rosati

2018 Life Sciences Securities Litigation Roundup

2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2019

TSCA/FIFRA/TRI - EPA Proposes Joint Stipulation In Ellis Case Requiring EPA To Issue ESA Effects Determinations For Two Neonicotinoid Pesticides: On December 12, 2018, EPA announced a proposed joint stipulation and proposed...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, November 2018

TSCA/FIFRA/TRI - EPA Issues Final TSCA Fees Rule: On October 17, 2018, EPA issued a final fees rule under TSCA. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule....more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2018

TSCA/FIFRA/TRI - EPA To Host Best Practices For Ground Application Webinar: On September 20, 2018, EPA announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2018

TSCA/FIFRA/TRI - EPA Issues Two Direct Final Rules Promulgating SNURs For 29 Chemicals: On August 27, 2018, EPA issued two direct final rules promulgating significant new use rules (SNUR) under TSCA. The first direct final...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2018

TSCA/FIFRA/TRI - EPA’s Spring 2018 Unified Agenda And Regulatory Plan Released: On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the spring 2018 Unified Agenda and Regulatory Plan. OIRA states...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, May 2018

Overview: - Since enactment on June 22, 2016, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has implemented a muscular regulatory program expressing Congress’ intent for a new and improved Toxic...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

Bergeson & Campbell, P.C.

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

TSCA/FIFRA - EPA Extends Comment Period For Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On October 5, 2017, the U.S. Environmental Protection Agency (EPA)...more

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