News & Analysis as of

Antimicrobials

Hogan Lovells

FDA warns animal drug companies over unapproved antimicrobials, identifying “public health concerns”

Hogan Lovells on

In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal drugs for use in aquarium fish and...more

Bergeson & Campbell, P.C.

EPA Extends the Comment Period on the Proposed Framework to Assess the Risk to the Effectiveness of Human and Animal Drugs Posed...

On September 26, 2023, the U.S. Environmental Protection Agency (EPA) requested comment on a proposed framework to strengthen the assessment of antimicrobial-resistance risks associated with pesticide use. EPA, the U.S....more

Bergeson & Campbell, P.C.

EPA Seeks Public Comment on Whether to Limit the Scope of the Treated Article Exemption

The U.S. Environmental Protection Agency (EPA) published an advanced notice of proposed rulemaking (ANPRM) on October 12, 2023, soliciting public comment and suggestions on specific issues related to seed treated with...more

Bergeson & Campbell, P.C.

EPA Announces Release of Final Guidance and Methods to Control Public Health Pathogens on Soft Surface Textiles in Non-Residential...

On August 29, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of final guidance and methods for evaluating efficacy claims of antimicrobial products registered to reduce bacteria and viruses on soft...more

Bergeson & Campbell, P.C.

EPA Announces Release of Guidance for the Evaluation of Products for Claims against Viruses

By Heather F. Collins, M.S. and Lisa R. Burchi On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of draft guidance for the evaluation of products for claims against viruses. This new...more

Bergeson & Campbell, P.C.

EPA Announces Efforts to Close Out Specific Antimicrobial Notification Actions to Reduce Backlog and Improve Efficiencies

On June 29, 2023, the U.S. Environmental Protection Agency (EPA) announced a new effort closing out notification actions for minor pesticide label or product formulation changes in an effort to reduce the backlog, which, EPA...more

A&O Shearman

European Union to introduce a transferable exclusivity voucher to incentivize the development of new antimicrobials

A&O Shearman on

The European Commission (EC) has just published its draft proposals to overhaul the European Union (EU) general pharmaceutical legislation. Tackling the problem of antimicrobial resistance was a key priority in the 2020...more

Bergeson & Campbell, P.C.

USDA Researchers Develop Natural, Washable, Antimicrobial Cleaning Wipes Using Nanocomposite Raw Cotton Fiber

The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for...more

Bergeson & Campbell, P.C.

NIA Posts Recording of Antimicrobial Treatment Webinar

The Nanotechnology Industries Association (NIA) has posted a recording of its March 6, 2023, webinar on “Nano in Action: Antimicrobial Treatment.” The webinar explored a topic where relevance has been amplified by the...more

Bergeson & Campbell, P.C.

EPA Launches Modernized DfE Logo for Disinfectant and Other Antimicrobial Products

The U.S. Environmental Protection Agency (EPA) announced on May 11, 2022, that it is launching a new, modern Design for the Environment (DfE) logo that will appear on antimicrobial products like disinfectants and sanitizers...more

Fox Rothschild LLP

Data Collection of Antimicrobial Use In Animals

Fox Rothschild LLP on

Concerns about the potential for antibiotic resistance started when they were first introduced as life-saving tools in human medicine. Despite such concerns, the importance of these tools for public and animal health have...more

Bergeson & Campbell, P.C.

EPA Announces Extension of Emerging Viral Pathogens Guidance for COVID 19

On November 19, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that...more

Beveridge & Diamond PC

EPA Indefinitely Extends COVID-19 Emerging Viral Pathogen Guidance

Beveridge & Diamond PC on

Key Takeaways: • What Happened: EPA has indefinitely extended its activation of the emerging viral pathogens guidance for antimicrobial pesticides, permitting registrants with a pre-qualified “emerging viral pathogen...more

Bergeson & Campbell, P.C.

ISO Publishes Standard on Evaluating the Antimicrobial Performance of Textiles Containing Manufactured Nanomaterials

The International Organization for Standardization (ISO) recently published ISO/TS 23650:2021, “Nanotechnologies — Evaluation of the antimicrobial performance of textiles containing manufactured nanomaterials.” ISO states...more

Bergeson & Campbell, P.C.

EPA Announces Revisions to Guidance to Ensure Effectiveness of Antimicrobial Pesticides against Candida auris

On October 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it has revised its guidance for evaluating the efficacy of antimicrobial pesticides against Candida auris (C. auris). EPA states that...more

Morgan Lewis - Well Done

Anti-Spoil(er) Alert: FDA Issues Guidance on Antimicrobial Agents in Food

Morgan Lewis - Well Done on

FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more

Bergeson & Campbell, P.C.

EPA Announces Penalty Issued against Southern California Company for Selling Illegal Antimicrobial Products

On August 25, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a penalty against Seychelle Environmental Technologies, Inc. (Seychelle), based in Aliso Viejo, California, for violations of the...more

Faegre Drinker Biddle & Reath LLP

Antimicrobial Marketing Claims: What You Need to Know to Mitigate the Risk of EPA Enforcement

Since the SARS-CoV-2 pandemic began, many companies have continued to develop antimicrobial products and devices to address health and safety concerns. Many of those companies are surprised to learn that the way in which they...more

Fox Rothschild LLP

FDA Issues Guidance #263 Recommending That Animal-Approved Over-The-Counter Medially Important Antimicrobial Drugs Are Required To...

Fox Rothschild LLP on

FDA has continued to exercise its authority, via guidance documents, which FDA says, while not legally enforceable, represent the agencies current thinking on the topic. To further the judicious use of medically important...more

Bergeson & Campbell, P.C.

EPA Announces It Is Taking Action in Response to Supply-Chain Disruptions for Inert Ingredients

On July 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it is taking action to alleviate a supply-chain issue facing the pesticide industry. EPA stated that it is allowing registrants of non-antimicrobial...more

Fox Rothschild LLP

FDA Issues Guidance Recommending That Animal-Approved Over-The-Counter Medically Important Antimicrobial Drugs Are Required To Be...

Fox Rothschild LLP on

FDA recently published Guidance #263 titled, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to...more

Kilpatrick

Legislative Update: The PASTEUR ACT – Incentivizing Discovery and Development of Novel Antimicrobial Drugs

Kilpatrick on

With everything that was happening this past winter, it would have been easy to miss the introduction of S. 4760: The PASTEUR Act. On December 9, U.S. Representatives Mike Doyle (D-PA) and Drew Ferguson (R-GA) introduced the...more

Kilpatrick

Legislative Update: Incentivizing Discovery and Development Investment into Novel Antimicrobial Drugs

Kilpatrick on

According to the Centers for Disease Control and Prevention (CDC) 2019 report Antibiotic Resistance Threats in the United States (“CDC Report”), “more than 2.8 million antibiotic-resistant infections occur in the United...more

Bergeson & Campbell, P.C.

Health, Environment, and Justice Organizations Seek Clarification from ECHA on Nano and Biocidal-Treated Products

On January 20, 2021, Health Care Without Harm (HCWH) Europe and 12 other health, environment, and justice organizations sent a letter to Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA) “seeking...more

Bergeson & Campbell, P.C.

EPA Announces New Policy for Registrants Voluntarily to Disclose Inert Ingredients in Antimicrobial Products

On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in...more

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