FDA Law Blog

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. More notably, Ms.

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LawTechnologyToday

SEPTEMBER 5, 2023

In recent years, new technology, specialization, client demand, and the pandemic forced the legal industry to adopt more efficient practices, including embracing the use of virtual legal services. ALSPs bring an innovation mindset to the legal industry that can prove invaluable to companies.

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FDA Law Blog

NOVEMBER 6, 2023

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. This implies that FDA may engage with companies on a more frequent basis than the standard (although unobserved, in practice) 2-year cycle. By Douglas B.

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InHouseBlog

AUGUST 15, 2023

This webinar is for all lawyers at all levels, whether in-house, in private practice, or in a government role. Panelists will include: Matt Karmel – Principal and Chair, Environmental and Sustainability Practice, Offit Kurman, P.A. Founded in 1987, the firm’s 280+ attorneys counsel clients across more than 30 areas of practice.

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FDA Law Blog

DECEMBER 7, 2023

We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing. He also noted that the VSD “does not supplant existing obligations to report to appropriate regulatory agencies, nor is it intended to alter those existing practices and channels of communication.”

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FDA Law Blog

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. life sciences industry. The firm’s clients are as diverse as the regulatory issues they face.

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Patently O

APRIL 17, 2024

John Howells, Ron D Katznelson, Freedom to Operate analysis as competitive necessity—the Selden automobile patent case revisited , Journal of Intellectual Property Law & Practice (2024). This is a well done student note, perhaps because author already had a PhD in chemistry prior to law school and was practicing patent agent.

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LawTechnologyToday

OCTOBER 22, 2021

It has become an integral part of the value proposition, not just for technology companies, but for every organization in every industry. Compliance with industry regulations, such as HIPAA for healthcare information or PCI-DSS for payment card data, is only the bare minimum. Get started today with your private OneStop Portal App.

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The Fashion Law

SEPTEMBER 6, 2021

The existing regulatory landscape. Globalization has fueled the rapid growth of the $30 billion-plus fast fashion industry, and yet, at the same time, it presents a barrier to harmonization. Therein lies the challenge of trying to regulate a global industry without standardized practices. Solutions for the future?

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LawSites

APRIL 28, 2022

The group soon began to expand, Pilc said, as more law firms started to join, because their clients were asking about cryptocurrency and blockchain, and then more technology companies joined, because their customers were asking questions about the legal and regulatory issues. Read more about Epiq in the LawNext Legal Technology Directory.

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The Process Street

JANUARY 1, 2024

For companies that operate in fast-paced industries with a regularly changing market, an agile QMS is crucial to make sure that the company processes aren’t too locked in place and arduous to make changes to. Implementing the right software can create a more efficient business with a happier team.

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Attorney at Work

FEBRUARY 21, 2022

What does it take to become a successful lawyer in your particular niche or practice area? In a series of in-depth interviews for the Estrin Report , Chere Estrin profiles top lawyers from all types of practices. Know your client’s business and industry. Or maybe the government is reading the standards wrong.

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Customs & International Trade Law

DECEMBER 24, 2023

Departments of Commerce, State, Justice, Treasury and Homeland Security published a joint Quint-Seal Compliance Note , “Know Your Cargo: Reinforcing Best Practices to Ensure the Safe and Compliant Transport of Goods in Maritime and Other Forms of Transportation.” On December 11, 2023, the U.S. authorities. authorities.

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Customs & International Trade Law

JANUARY 24, 2024

The US Department of Commerce’s Bureau of Industry & Security (BIS) is charged with enforcing EAR under 15 C.F.R. The EAR governs whether a person or entity may: Export an item from the US. parts 730-774. Reexport that item from a foreign country. Transfer an item from one person to another.

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Broadcast Law Blog

MAY 20, 2023

Here are some of the regulatory developments of significance to broadcasters from the past week, with links to where you can go to find more information as to how these actions may affect your operations. That reallocation has resulted in a proposed decrease in the 2023 fees to be paid by broadcasters. from last year.

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Broadcast Law Blog

OCTOBER 1, 2022

Comments are due October 26 , with reply comments due November 25, 2022 on the FCC’s request for comment on the methodology that it uses to allocate its employees to determine annual regulatory fees. This proceeding is important, as the allocation of FCC employees determines the regulatory fees paid by each industry regulated by the FCC.

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InHouseOps

JUNE 6, 2022

CCBJ: Tom, how does the approach to ESG compliance differ based on an organization’s size, maturity, and industry? Tom O’Neil: It is important to take a step back, unpack ESG, and understand the trajectories of those three pillars—environmental, social and governance—which have now coalesced to become a north star for most organizations.

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LawTechnologyToday

SEPTEMBER 7, 2023

Julie founded Standd after over a decade practicing law, mostly as a trial attorney at the U.S. At DOJ, Julie served in the Tax Division, Civil Division, and Federal Programs Branch, where she handled cases raising complex regulatory and administrative law questions in federal trial and appellate courts across the US.

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Constitutional Law Reporter

JANUARY 17, 2024

The Alliance for Hippocratic Medicine-an association of doctors who research, teach, and advocate for ethical medical practices-several similar organizations, and several individual doctors filed suit. It ultimately removed that requirement from mifepristone’s conditions for use. In Danco Laboratories, L.L.C. whether the U.S.

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Attorney at Work

JANUARY 5, 2022

Attorney at Work’s new “You at Work Spotlight” series focuses on the crucial role business professionals play in law firms of all sizes — including newly emerging career options in the legal industry. Oden: Oregon and Florida have vastly different political climates, different cultural nuances and distinct local government regulations.

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InHouseOps

JULY 25, 2022

What does it take to have a modern law approach to practice? Recently, the phrase “modern law” has been floating around in the legal industry. Collaboration between legal and tech professionals is the driving force towards a new way to practice law. What does it take to have a modern law approach to practice?

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The Process Street

NOVEMBER 28, 2023

It was once the stuff of utopian science fiction and huge enterprises, but now practically anyone can take advantage. Source ) A decade ago, the technology was hardly mature enough to be of any practical use. Source ) A decade ago, the technology was hardly mature enough to be of any practical use.

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The Fashion Law

OCTOBER 28, 2021

All the while, businesses have a checkered history when it comes to engaging with societal problems, from self-serving “box ticking” corporate practices under the guise of social responsibility to shifting responsibility to consumers to make ethical choices, such as reusable coffee cups. Transformative Branding in Practice.

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Intelligize Blog

JULY 13, 2023

Not so long ago, corporations routinely came under fire for using bonuses to incentivize executives to make decisions that fattened the bottom line at the expense of environmental, social and governance concerns – known today as ESG. Best practices and guiding principles for making those awards remain in flux, however.

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Chugh LLP

DECEMBER 30, 2021

Privacy notices can cover a variety of topics depending on the organization’s business practices and industry standards. Consumer’s rights or choices regarding the collection, use, and sharing of their data, including how to opt-in or opt-out of these practices. Legal and Regulatory Requirements. Use of cookies.

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LexForti

FEBRUARY 19, 2022

Strengthening the Socially Informed Model of Arbitration under the Industrial Code, 2020: A Constructive Critique’ by Aaryan Mohan & Anannya Chitranshi. ‘A The firm has strong capabilities and deep industry knowledge across all its practice areas. About the Judges.

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FDA Law Blog

AUGUST 29, 2021

The federal government does its own version of rebranding with each change in administration. As a matter of administrative law, the Brand Memo made good sense from the perspective of FDA-regulated industry, as we described here. electronic formatting for regulatory submissions), scientific (e.g.,

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Broadcast Law Blog

JULY 17, 2022

Here are some of the regulatory developments of significance to broadcasters from the past week, with links to where you can go to find more information as to how these actions may affect your operations. The associations also highlighted the potential impact of ZoneCasting on public safety, listeners and the economics of the radio industry.

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ClimateChange-ClimateLaw

JANUARY 10, 2022

However, these climate-friendly practices are employed on only a tiny fraction of US agricultural land; policy change is needed to accelerate their adoption. Farmers and ranchers can reduce greenhouse gas emissions through improved grazing and feeding practices and better manure, irrigation, crop and soil management.

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FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” A considerable roadblock in the development of RMT products is a lack of regulatory predictability.

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SCOTUSBlog

JANUARY 4, 2024

The trial court ruled for ASEA, holding that the First Amendment “does not require the State to alter the union dues deduction practices in place prior to” the attorney general opinion. Among other grounds, the companies contended that Minnesota’s claims necessarily and exclusively arise under federal common law.

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The Fashion Law

SEPTEMBER 29, 2021

The COVID-19 pandemic accelerated the digitalization of the fashion industry – including for luxury brands, which have historically been slow to embrace electronic and digital commerce. Miriam Farhi is the Co-Chair of Perkins Coie’s Privacy & Security practice and Vice Chair of the firm’s Technology Transactions & Privacy practice.

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LawTechnologyToday

DECEMBER 11, 2020

Evidenced by increased adoption for major industrial applications with the OOC Oil & Gas Blockchain Consortium , a powerful network of 10 major oil and gas players; alongside the Construction Industry Institute at The University of Texas’ recent Operating System 2.0 (OS2) Contradictory Language. Anticipating Data Glitches and Gaps.

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Customs & International Trade Law

JULY 22, 2022

With the Green Trade Strategy, CBP is looking to set an example for customs authorities around the world to develop higher, greener standards for global trade while creating an opportunity for government, industry, and the public to unify efforts in the creation of a more sustainable future. industries and U.S.

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The Fashion Law

DECEMBER 31, 2021

Known for aligning the cost of borrowing with a borrower’s performance measured against prescribed sustainability performance targets, green bonds are proving compelling for fashion industry entities. Companies’ S-1 Filings Are Getting Longer, Mentions of ESG Are Increasing.

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LegalTalkNetwork

SEPTEMBER 3, 2019

The Space Industry and Government Contracts. Finally, we visited the State Bar of California to attend its public forum associated with the regulatory proposals set forth by their Taskforce on Access Through Innovation of Legal Services (ATILS). ABA Annual Meeting 2019: Practice Tips for Construction Litigation.

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SCOTUSBlog

JULY 9, 2021

For the past 400 years, cockfighting has been practiced on the island and is still today proclaimed by Puerto Rican law to be a “cultural right of all Puerto Ricans.” And like a state, it is an autonomous political entity sovereign over matters not covered by the United States Constitution. In Ortiz-Diaz v.

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