FDA Law Blog

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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Drafting Manufacturing 59

Conflict of Laws

MARCH 1, 2024

Conventions & Instruments On 1 February 2024, the 2007 Child Support Convention entered into force for Canada. On 13 February 2024, Albania signed the 2005 Choice of Court Convention and the 2007 Maintenance Obligations Protocol. On 28 February 2024, the 2007 Child Support Convention entered into force for Azerbaijan.

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Depositions Drafting Litigation Litigating 56

FDA Law Blog

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

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Drafting Technology 59

Paralegal Bootcamp

JANUARY 25, 2024

These were the top 7 actionable strategies and tips for litigation paralegals to accelerate their paralegal career in 2024. A document management system that organizes the electronic version of everything in the case, like the Microsoft Word documents that you’re drafting, memos, etc.

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Paralegal Paralegals Litigation Litigating 227

CARET Legal

APRIL 24, 2024

The Legal Automation Bot Legal technology equipped with automation capabilities can perform repetitive tasks like drafting documents , handling client intake , and conducting compliance checks. The post The Best Legal Technology & Tools for Lawyers (2024) appeared first on CARET Legal. Ready to step into the future of legal tech?

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Legal Technology Solution Technology Legal Legal 92

CARET Legal

MARCH 13, 2024

Did you know that, according to a report by Zero , 85% of timekeepers spend one or more hours per workday drafting documents? In 2024, improving law firm efficiency is as important as ever as firms continue to face increasing pressure to improve performance, deliver services efficiently, and reduce costs. It’s so easy to get started.

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Law Firm Law Firms Legal Legal 108

JURIST

APRIL 11, 2024

The government’s draft law “On Amendments to Certain Legislative Acts of Ukraine on Improving Certain Issues of Mobilization, Military Registration and Military Service” was submitted by the Cabinet of Ministers to the Ukrainian Parliament Verkhovna Rada on December 25 , 2023. It was later returned to the government for revision.

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Laws Drafting Government 104

Paralegal Bootcamp

JANUARY 10, 2024

The key to accelerating your career in 2024 is learning eDiscovery and this blog is going to give you a 3-step plan for litigation paralegals to follow to make it happen. I feel so passionate about litigation paralegals learning about eDiscovery because I’ve seen what it can do for litigation paralegals’ careers.

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eDiscovery Paralegal Paralegals Litigation 148

CARET Legal

FEBRUARY 23, 2024

It not only saves time but also enhances the accuracy of legal research, contract review, and document drafting. Schedule a free demo and let’s explore how our innovative solutions can drive your firm’s success in 2024 and beyond! The post 2024 Law Firm Technology Trends to Be Aware Of appeared first on CARET Legal.

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Law Firm Law Firms Technology Legal Technology Solution 53

FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

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Manufacturing Drafting 59

FDA Law Blog

DECEMBER 12, 2023

The recommendations in the draft guidance address: The wording of UTH claims based on RSS for use on adult maintenance cat food labeling; The RSS criteria to substantiate those UTH claims; and The study data that CVM recommends to demonstrate the utility and target animal safety of the cat food. By Sophia R. Upper bound of 95% CI ≤ 2.5

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Drafting Manufacturing Laws 59

JURIST

DECEMBER 15, 2023

The government of the Australian state of Tasmania is seeking to ban conversion therapy practices in a recently released draft legislation. ” The draft legislation is meant to “prevent harm caused by practices that attempt to change or eradicate a person’s sexual orientation or gender identity.”

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Government Drafting Attorney Laws 104

Conflict of Laws

MARCH 1, 2024

Businesses and their legal advisers are encouraged to anticipate risks and consider appropriate measures when drafting contracts. van Vliet/J. Noyer: Acquisition of property according to the law applicable to contracts?

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Contract Drafting Court Laws 60

JURIST

NOVEMBER 14, 2023

The experts highlighted a disturbing surge in political violence , the arrest of senior opposition figures, and the widespread arbitrary detention of political activists in the lead-up to the national elections slated for 2024. However, the UN experts noted that thousands of cases related to freedom of expression remain pending under the DSA.

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Drafting Government Legal Legal 286

FDA Law Blog

APRIL 14, 2022

FDA published in the Federal Register a draft version of its MDUFA V commitment letter , which outlines FDA’s updated performance goals in reviewing device applications and planned process improvements. Similarly, if the 70% goal is met in FY 2024 and adequate fee revenue is provided, the goal will be adjusted to 90% in FY 2027.

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Drafting Calendaring Technology 40

LawSites

NOVEMBER 29, 2023

Lawyers and other filers would be required to certify either that they had not used AI in drafting the document or that, if they did, “a human” had reviewed the document for accuracy. Avianca , where two lawyers were sanctioned for filing a brief laden with bogus cases hallucinated by ChatGPT.

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Lawyer Lawyers Court Drafting 143

LawSites

NOVEMBER 14, 2023

The other, Lexis Create with Lexis+ AI, brings generative AI drafting assistance to the Lexis Create add-in for Microsoft Word. Now, with the addition of Lexis+ AI, Lexis Create users get access to generative AI functions directly while drafting a document in Microsoft Word. Generate a draft. Summarize a case.

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Drafting Legal Research Law School Legal 109

JURIST

JUNE 24, 2023

Under pressure from the West African ECOWAS bloc , Goita has committed to reinstating civilian rule by March 2024 after implementing crucial institutional reforms. Until now, the nation has only had a National Assembly; the proposed draft constitution establishes a two-chamber parliament, the National Assembly and the Senate.

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Drafting Government 197

JURIST

JUNE 13, 2021

The Bundestag adopted the draft law by a large majority. The law applies to companies with more than 3,000 employees as of 2023, and 1,000 employees in 2024. The resulting final draft requires companies to act on specific incidents, and then only if they have substantiated knowledge of the abuse.

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Diligence Laws Drafting Government 285

Conflict of Laws

OCTOBER 27, 2023

Abstracts should be no longer than 500 words and should be submitted by January 2 nd 2024 to nilr@asser.nl. If an abstract is accepted, this will be communicated by February 1 st 2024. After acceptance, draft papers are to be submitted at the latest by May 1st 2024. Submissions are limited.

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Litigation Litigating Drafting Legal 67

JURIST

JANUARY 17, 2024

The draft media law has been alleged to have issues related to its broad application, mandatory registration requirements, restrictions on foreign media, severe content restrictions, limitations on media ownership, and accreditation criteria for journalists. ” A forensic examination reportedly confirmed these calls on January 12, 2024.

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Drafting Laws Government 118

InHouseBlog

JANUARY 2, 2024

As we head into 2024, let’s recap some great resources for in-house counsel that made a large impact in 2023: Sterling Miller’s “Ten Things” Blog : With a keen eye and impressive wit, Sterling Miller provided a tremendous number of informative and useful resources for in-house counsel in 2023. Let us know !

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Contract Drafting Legal Legal 73

ClimateChange-ClimateLaw

MARCH 5, 2024

But the decision to include these sections in the latest draft of the IECC has generated sharp disagreement among trade associations, local governments, and energy efficiency advocates. The 2024 IECC sets energy conservation requirements for new buildings, including heating, ventilation, lighting, water heating, and power usage.

Construction 57

Construction Drafting Government Laws 57

FDA Law Blog

OCTOBER 16, 2023

In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

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Healthcare Drafting Technology 119

Customs & International Trade Law

DECEMBER 24, 2023

Reminder: the submission period for the 2024 Customs Broker Triennial Status Report (TSR) and associated $100 filing fee for all licensed customs brokers opened December 18, 2023. The TSR and $100 fee is due by February 29, 2024. The 2017 final guidance remains in effect until this draft guidance is finalized. U.S.

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eFiling Drafting Government Attorney 52

Paralegal Bootcamp

JULY 11, 2023

4 Pro Tips for Drafting Billable Time Entries How much do you love drafting billable time entries? In today’s blog, I’m going to give you four quick tips to help you draft better time entries. Think about some of those questions when you’re drafting your time entry. We spent four hours. Or worse yet, you spent.1

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Drafting Paralegal Paralegals Law Firm 246

Conflict of Laws

FEBRUARY 17, 2024

An abstract of 500-800 words should be submitted by 15 March 2024 to PIL.sustainability.CJTL@ed.ac.uk Selected contributors will be invited to submit a draft paper by 1 October 2024 in advance of a hybrid conference at Wuhan University in November 2024. Please include the contributor’s last name in the email title.

Laws 78

Laws Drafting 78

MyCase

APRIL 24, 2024

According to the Legal Industry Report 2024 , nearly one-quarter (24%) of law firms have adopted legal-specific generative artificial intelligence (GAI) tools. Survey respondents confirmed they use GAI to streamline firm processes, from drafting marketing content to finding specific statutes. Drafting marketing content.

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Legal Legal Drafting Legal Research 52

Paralegal Bootcamp

JANUARY 4, 2024

Three primary areas of case management responsibility include: Draft pleadings and discovery. Draft pleadings and discovery. Draft pleadings and discovery. Many attorneys also rely on the paralegal to do the first-round draft of pleadings that will be filed with the court. Assist at trial. What does that mean?

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Paralegal Paralegals Litigation Litigating 130

Customs & International Trade Law

FEBRUARY 9, 2024

Annual quota opening February 7, 2024: QB 24-507 2024 Solar Cells and Modules – Crystalline Silicon Photovoltaic (CSPV) Solar Cells February 7, 2024, to February 6, 2025 – 5,000,000,000 watts (5.0 million, had the merchandise been genuine.

Technology 52

Technology Drafting Manufacturing Government 52

Conflict of Laws

JANUARY 19, 2024

An abstract of 500-800 words should be submitted by 20 Feburary 2024 to PIL.sustainability.CJTL@ed.ac.uk Selected contributors will be invited to submit a draft paper by 1 October 2024 in advance of a hybrid conference at Wuhan University in November 2024. Please include the contributor’s last name in the email title.

Laws 64

Laws Drafting 64

JURIST

DECEMBER 30, 2023

The bill was drafted in the context of a Public Health Emergency that has been in place in British Columbia since 2016 due to a sharp uptick in drug use. In November, HRNA challenged the act’s constitutionality, requesting an interim injunction of the bill until March 31, 2024.

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Court Drafting Government Laws 104

JURIST

MARCH 3, 2022

The United Nations Environment Assembly Wednesday approved a resolution to establish the first-ever global agreement on plastic pollution, along with a series of draft resolutions concerning biodiversity, health, the green economy, and circularity. ” The treaty will likely be finalized in 2024.

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Manufacturing Drafting Legal Legal 197

LawSites

JANUARY 9, 2024

Even before the advent of generative AI, several contracts technology products sought to streamline this process — most typically by comparing a draft received from a counterparty with a company’s own contracts playbook and substituting the company’s preferred language for that proposed by the counterparty.

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Contract Drafting Technology Legal 69

FDA Law Blog

JUNE 20, 2023

Predetermined Change Control Plans As our readers will know, FDA recently issued a draft guidance related to Predetermined Change Control Plans (PCCPs) (see our prior post here ). Draft Guidance Finally, as part of MDUFA V , FDA has committed to issuing an updated draft of this Q-Sub guidance, by March 31, 2024.

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Drafting 45

Conflict of Laws

FEBRUARY 16, 2024

In its judgment of 8 February 2024, the CJEU had to decide whether “ the application of the Brussels Ibis Regulation be based solely on the fact that two parties with their seat in the same Member State agree on the jurisdiction of courts of another EU Member State.”

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Court Drafting Contract Legal 67

MyCase

MAY 2, 2024

Join us as we reveal the top legal AI companies trailblazing the way to a more efficient and successful 2024 and beyond. The platform automates repetitive aspects of drafting legal documents, particularly discovery documents, to expedite the process and improve efficiency. How to Get Started With Legalyze.ai: Visit the Legalyze.ai

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Document Review Legal Legal Legal Documents 52