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Articles by Benjamin Wolf
Client Alert: “Power” to the New York City People?: A UDAAP Legislation with Teeth
New York City is on the verge of altering the legal landscape concerning unfair, deceptive, abusive acts and practices (proverbially known as UDAAP) claims;[1] all to the benefit of consumers and businesses abiding by the law, and a warning to businesses (think bank accounts, credit cards, cryptocurrency, used motor vehicles, solar energy systems, certain app/web-based services etc.), based on a certain number of employees and gross revenue, skirting the law. On Oct.
San Marino High School Is One of State's Best
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FDA Proposes Tobacco Registration and Listing Rule Targeting Foreign Manufacturers
Our FDA: Drug & Device Team reviews a rule proposed by the Food and Drug Administration (FDA) that would require foreign tobacco product manufacturers to register their establishments and submit product listings, expanding oversight of imported tobacco products.
Elevated CO 2 and warming intensify plant reliance on soil nitrogen reserves despite intensive fertilization
Abstract Understanding how ecosystems sustain plant nitrogen (N) supply under climate change is critical, yet whether increasing plant N demand is met by external inputs or mobilization of soil N reserves remains unresolved. Here we show that climate change increases plant reliance on soil N reserves despite intensive fertilization.
Biological Products Regulation Part 4: Biosimilars 101 | JD Supra
Executive Summary In the fourth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the Food and Drug Administration’s requirements and standards for approval of biosimilar products.
Biological Products Regulation Part 3: Unlocking Reference Product Exclusivity: What Sponsors Need to Know | JD Supra
Executive Summary In the third part of our FDA: Drug & Device Team’s series on biological products regulation, we investigate how to qualify for reference product exclusivity (RPE) under the Biologics Price Competition and Innovation Act.
Biological Products Regulation Part 2: What Is the Regulatory Pathway for Biological Products? | JD Supra
Executive Summary In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service Act.
Biological Products Regulation Part 1: Is the Product a Biological Product? | JD Supra
Executive Summary In the first part of our FDA: Drug & Device Team’s series on biological products regulation, we explain what qualifies as a “biological product” and how the Food and Drug Administration classifies them.
Comparative Efficacy Studies Are No Longer the Default Requirement for Biosimilars | JD Supra
Our FDA: Drug & Device Team examines the FDA’s new draft guidance that allows biosimilar developers to rely more on analytical and pharmacokinetic data, reducing the need for costly and time-consuming comparative efficacy studies.
Six New Teachers Will Add to San Marino High's Status
State AlabamaAlaskaArizonaArkansasCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaOhioOklahomaOregonPennsylvaniaRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUtahVermontVirginiaWashingtonWashington D.C.West VirginiaWisconsinWyomingPuerto RicoUS Virgin IslandsArmed Forces AmericasArmed...
Commerce Seeks Comments on Section 232 Pharmaceutical Investigation | JD Supra
Yesterday, April 16, 2025, the Bureau of Industry and Security (BIS), a bureau within the U.S. Department of Commerce, published a “Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients.” As background under Section 232 of the Trade Expansion Act of 1962, if the BIS investigation concludes that excessive foreign imports are a threat to national security, the President may levy tariffs on those imports.
Addressing Data Integrity Challenges in Medical Device Submissions | JD Supra
The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device Team shares best practices for applicants that engage third-party laboratories to generate data for their FDA submissions.
FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies | JD Supra
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health emergencies (PHEs).
Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110 | JD Supra
Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing.
What’s in the FDA Final Rule Regulating Laboratory-Developed Tests as Medical Devices? | JD Supra
Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs).
Unraveling a hidden player in lymphovascular invasion in bladder cancer
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Unraveling a hidden player in lymphovascular invasion in bladder cancer
Zheng et al. uncover the cellular landscape in early-stage BCa and report a CAF subset characterized by PDGFRα and ITGA11. They demonstrate that PDGFRα+ITGA11+ CAFs stimulate lymphangiogenesis and align ECM to assist BCa cell intravasation, facilitating the LVI and LN metastasis of early-stage BCa, which provides a potential therapeutic target.
Interview mit Gründer Gerald Babel-Sutte
THE RED BULLETIN INNOVATOR: Die Urban Future ist die wichtigste Konferenz für nachhaltige Stadtentwicklung in Europa. Was macht euch so besonders? Unser Fokus. Jedes Jahr ist eine andere innovative Stadt Gastgeberin der internationalen Veranstaltung. Expertinnen und Entscheider aus Politik, Wirtschaft und Zivilgesellschaft bündeln ihr Know-how und ihre Leidenschaft, damit in unseren Städten endlich Veränderung passiert.
Divalent Lanthanide Tetraisobutylaluminates: Reactivity and Living Isoprene Polymerization
Graphical Abstract Homoleptic isobutylaluminates [Ln(AliBu4)2] (Ln=Sm, Eu, Yb) display single-component catalysts for cis-1,4-selective isoprene polymerization. Chlorination with C2Cl6 affords highly symmetric, mostly inactive clusters such as mixed-valent [Sm6Cl8(AliBu4)6], while activation of [Yb(AliBu4)2] with [PhNMe2H][B(C6F5)4] gives divalent “[Yb(AliBu4){AliBu3(PhNMe2)}][B(C6F5)4]” promoting ideal living polymerization.
Public Health Emergency Set to End May 11, 2023: What It Means for FDA-Regulated Firms and Products | JD Supra
The coming end to the COVID-19 public health emergency doesn’t mean the end of all FDA authorities exercised during the pandemic. Our FDA/Food, Drug & Device Team explores what will happen to the FDA’s emergency use authorizations and COVID-19 enforcement guidances, among other enforcement policies currently in effect. Which guidances will remain in effect beyond May 11? Does the FDA have a transition plan? Inspections have already returned, but when will the FDA resume in-person meetings?
Investigation of the influence of fine recycled sand on the setting behaviour of cement when used as supplementary cementitious material (SCM)
MATEC Web of Conferences 364, 05009 (2022) Investigation of the influence of fine recycled sand on the setting behaviour of cement when used as supplementary cementitious material (SCM) *, and Munich University of Applied Sciences, Department of Civil Engineering, 80333 Munich, Germany * Corresponding author: This email address is being protected from spambots. You need JavaScript enabled to view it.
Bringing Dietary Supplements to Market: Key Requirements and Best Practices | JD Supra
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. Our Food & Beverage and FDA teams explore the best practices for you to follow and avenues toward approval and success. What is a dietary supplement? Pathways to market Pitfalls to avoid The dietary supplement market is a growing industry.
Bringing Dietary Supplements To Market: Key Requirements And Best Practices
To print this article, all you need is to be registered or login on Mondaq.com. Executive Summary Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. Our Food & Beverage and FDA teams explore the best practices for you to follow and avenues toward approval and success. What is a dietary supplement?
Practical Considerations
United States: Practical Considerations For Draft Transition Plans For Devices Under EUAs Or COVID Enforcement Policies 21 January 2022 Alston & Bird To print this article, all you need is to be registered or login on Mondaq.com. On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic.
Practical Considerations for Draft Transition Plans for Devices Under EUAs or COVID Enforcement Policies
JHVEPhoto / Alamy Stock Photo A close look at FDA's transition measures for devices under EUA's and COVID-19 policies. Benjamin Wolf | Jan 14, 2022 On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic. The declaration of a PHE enabled FDA to issue a declaration regarding the appropriateness of utilizing emergency use authorizations (EUA).
Episode 90: arc42 - ein pragmatischer Ansatz zur Dokumentation
Softwaredokumentation ist bei vielen unbeliebt. In dieser Folge des SoftwareArchitekTOUR-Podcast sprechen Gernot Starke, Ben Wolf und Peter Hruschka über arc42. SoftwareArchitekTOUR 04.01.2022 09:04 Uhr Gernot Starke, Benjamin Wolf, Dr. Peter Hruschka – 0 Kommentare arc42 ist ein pragmatischer Ansatz zur Kommunikation und Dokumentation von Software- und Systemarchitekturen. Es ist Open Source und kommt in vielen Organisationen unterschiedlicher Branchen zum Einsatz.
MA 35 Official: “We don’t pick up the phones.”
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Coronavirus in Austria | Shops, Services Reopen Today
Numbers For current numbers, check the website of Ministry of Health and the AGES dashboard. Resources The City of Vienna has compiled comprehensive information on questions and answers regarding coronavirus and the COVID-19 disease in English. The Austrian Ministry of Health has put together FAQs on the coronavirus and also provides material to download on how to protect yourself and others from the disease, also in English.
Austria Deports Children by Night, Triggering Outrage and Protests
Children awaiting deportation. /(C) Florian Klenk In the dead of the night, in the middle of a raging global pandemic, Austria’s Interior Ministry chartered a plane to deport children back to the Eastern Caucasus. Among those to be deported are 12-years-old Tina and her sister 5-years-old Lea, who were both born in Austria, as well as their older brother. Falls ihr geschlafen habt. Das ist in den letzten drei Stunden passiert. Drei Kinder warteten drei Stunden im Bus auf die Abschiebung.
Polymeric dimethylytterbium and the terminal methyl complex (TptBu,Me)Yb(CH3)(thf)
Polymeric dimethylytterbium and the terminal methyl complex (TptBu,Me)Yb(CH3)(thf)† Divalent ytterbium bis(trimethylsilyl)amides [Yb{N(SiMe3)2}2]2 and Yb[N(SiMe3)2]2(thf)2 react with purified methyllithium to amorphous dimethylytterbium [YbMe2]n. The characterisation was performed by 171Yb and 13C CP/MAS NMR spectroscopy as well as by conducting protonolysis reactions with HC5Me5 and HTptBu,Me, affording known (C5Me5)2Yb(OEt2) and new (TptBu,Me)Yb(CH3)(thf).
Generally Recognized as Safe: Establishing a Suitable U.S. Regulatory Status for Food Ingredients | JD Supra
What are the benefits and drawbacks of coming to an independent generally recognized as safe (GRAS) conclusion for a novel food ingredient compared to filing a GRAS notification with the FDA? Our Food & Beverage and FDA teams provide insight into the FDA’s GRAS regulatory pathway as a continuation of this series exploring best practices for premarket food approval. GRAS notification to the FDA What do you need in your files to market a product based on an independent conclusion of GRAS status?
The top 5 regulatory issues for US food launches in 2021
Launching a new food product in the US? Here’s the top five regulatory issues to watch out for next year. As we approach the end of 2020, this article looks back on the top five regulatory issues affecting ingredient suppliers and food manufacturers seeking to bring new products to market in the US.
Polymeric dimethylytterbium and the terminal methyl complex TptBu,MeYb(CH3)(THF)
Polymeric dimethylytterbium and the terminal methyl complex TptBu,MeYb(CH3)(THF) Divalent ytterbium bis(trimethylsilyl)amides [Yb{N(SiMe3)2}2]2 and Yb[N(SiMe3)2]2(thf)2 react with purified methyllithium to amorphous dimethylytterbium [YbMe2]n. The characterisation was performed by 171Yb and 13C CP/MAS NMR spectroscopy as well as by conducting protonolysis reactions with HC5Me5 and HTptBu,Me, affording known (C5Me5)2Yb(OEt2) and new (TptBu,Me)Yb(CH3)(THF).
How Vienna Plans to Mass Test the Population for COVID-19
Vienna’s City Councilor of Health, Peter Hacker (SPÖ) (c) Peter Hacker / Facebook Shortly after the beginning of the lockdown, Chancellor Sebastian Kurz (ÖVP) announced that the government plans to mass test the population in December and January. Such mass testing campaigns have recently been tried in neighboring Slovakia – which tested 2/3 of its population in November – and in South Tyrol.
Strategic Approaches for Establishing a Suitable U.S. Regulatory Status for Food Ingredients and Dietary Supplements | JD Supra
What does it take to clear regulatory hurdles to bring food and drugs to market? Our Food & Beverage and FDA teams begin a series exploring best practices for you to follow and the many avenues to approval and success. First: laying the foundation. What is a food additive? Does my product have an existing regulatory clearance?
An Old Drug for a New Emergency: FDA Issues New Guidance on the Use of Convalescent Plasma for COVID-19 | JD Supra
The Food and Drug Administration released guidance for the use of convalescent plasma to treat COVID-19 to supplement its recently issued emergency use authorization. Our Food, Drug & Device/FDA Team analyzes the specifics of when and how convalescent plasma can be used and how the FDA will enforce compliance. Under what conditions can convalescent plasma be used under the EUA? Under what other conditions may convalescent plasma be used? How must convalescent plasma be collected?
Austria to Open Borders to All Neighbors – Except Italy | Metropole
Starting on June 4, Austria will open the borders to Germany, Liechtenstein, Switzerland, Slovakia, Slovenia, Czechia and Hungary. Travelers from these countries won’t need to go into quarantine or present a negative COVID-19 test result. The Austrian government announced Wednesday that borders with all neighboring states except Italy would be open as of tomorrow, Thursday, June 4, 2020.
FDA Continues to Accelerate Availability of COVID-19 Tests | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Help Us Help You | Metropole – Vienna in English
When we founded Metropole, we wanted to help people feel at home in Vienna and explore everything the city has to offer. Little did we know we would one day tell them to stay at home, for everyone’s safety. We knew an English-language media house had potential – more than 500,000 people across Austria speak better English than German.
The Coronavirus in Austria & Vienna | Latest News | Metropole – Vienna
Two weeks after the first cases of coronavirus were diagnosed in Austria, the situation in Europe has gone from worrisome to grave. Italy has been on lockdown since March 9, 2020, spurring other governments, businesses, organizations and individuals into action – also in Austria. Here is a wrap-up of the measures currently in place in Austria, as they were announced.
FDA Seeks Help to Solve Personal Protective Equipment Shortages | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Differentiated agonistic antibody targeting CD137 eradicates large tumors without hepatotoxicity
Research ArticleImmunologyOncology Free access | 10.1172/jci.insight.133647 Ugur Eskiocak,1 Wilson Guzman,1 Benjamin Wolf,1 Christine Cummings,1 Lauren Milling,1,2 Hsin-Jung Wu,1 Michael Ophir,1 Conner Lambden,3 Pearl Bakhru,1 Dana C. Gilmore,1 Samantha Ottinger,1 Lucy Liu,1 William K. McConaughy,1 Sunny Q. He,1 Chao Wang,3 Cheuk Lun Leung,1 Jason Lajoie,1 William F. Carson IV,1 Nora Zizlsperger,1 Michael M. Schmidt,1 Ana C. Anderson,3 Piotr Bobrowicz,1 Thomas J.
Surgical resection based on ontogenetic cancer field theory for cervical cancer: mature results from a single-centre, prospective, observational, cohort study
Summary Background Previous findings from our centre suggest that carcinoma of the cervix propagates within ontogenetic cancer fields, tissue compartments defined by staged morphogenesis. We aimed to determine whether surgical treatment that accounts for stage-associated, ontogenetic cancer fields and their associated lymphoid tissues results in locoregional tumour control without the need for adjuvant radiotherapy.
Austrian Railways Set New Records
Austria is not what you would call a natural railway country. With an average elevation of 910 meter – from the 3,789-meter-high peak of the Großglockner to Lake Neusiedel at a mere 115 meters above the sea level – locomotives must huff and puff up the mountains and down to get to their destinations. To say nothing of the long East-West stretch from the Slovak border to Switzerland, which makes classical hub networks, such as the French one centered on Paris, all but impossible.
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