MyCase

AUGUST 8, 2022

If you’ve ever used tools like Google Workspace, Microsoft 365, or MyCase legal practice management software, you’re familiar with SaaS—software as a service. SaaS is modernizing the legal industry in two ways: by making law firms more efficient and creating career opportunities for lawyers worldwide. Benefits of Legal SaaS.

Lawyer 52

Lawyer Lawyers Legal Legal 52

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 United Nations estimates the global plastic industry is valued at US$522.6

Manufacturing 197

Manufacturing Drafting Legal Legal 197

The Estrin Report

JANUARY 30, 2023

By Lawrence Pascoe Compared to other businesses, lawyers have not evolved in how they serve their clients Let’s be honest; the way lawyers serve their clients has not changed much , not just from the late 1970s when I started practicing law but probably since the 1200s when England passed laws regulating the conduct of the legal profession.

Lawyer 233

Lawyer Lawyers Legal Services Law Firm 233

Rocket Matter

MAY 2, 2023

Invented after World War II by Toyota engineers struggling to maintain productivity amid massive supply chain disruptions, lean methodologies revolutionized modern manufacturing. Smart business leaders are always looking for the next big thing and soon adapted the lean principles of manufacturing to everyday business practices.

Legal 52

Legal Legal Law Firm Law Firms 52

FDA Law Blog

DECEMBER 15, 2022

It issued a draft guidance in 2017 which was subsequently revised in 2019. The final guidance issued last week is the same as the 2019 draft guidance except that the final guidance includes a paragraph in which FDA mentions that the provisions of the CARES Act regarding OTC monograph reform do not apply to homeopathic drug products.

Drafting 98

Drafting Manufacturing Legal Legal 98

The Fashion Law

OCTOBER 4, 2021

This summer, the European Commission released a draft version of the European Union Vertical Agreements Block Exemption Regulation (“VBER”) along with draft revised guidelines on vertical restraints to supplant the existing guidance on vertical agreements (i.e.,

Manufacturing 64

Manufacturing Drafting Contract Legal 64

JURIST

DECEMBER 16, 2021

” Newsom had his own fair share of words on the decision and explained his directive to authorize private citizen suits against gun manufacturers and distributors: “I am outraged by yesterday’s U.S. Newsom has been a roll since convincingly surviving a recall effort against him in September.

Court 208

Court Manufacturing Attorney Court Decisions 208

Strictly Business

DECEMBER 21, 2023

In most cases, the first draft of an LOI will be used by the buyer to present its formal offer; however, in some cases, the seller will initially present the terms it is willing to accept. It is important that the parties clearly and specifically state which provisions, if any, are legally binding and which are not.

Diligence 85

Diligence Drafting Contract Real Estate 85

FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Drafting 64

Drafting Manufacturing Technology Legal 64

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing 105

Manufacturing Calendaring Statute Administrative Law 105

FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing. By Philip Won & Jeffrey K.

Laws 105

Laws Manufacturing Drafting Technology 105

LegalTalkNetwork

FEBRUARY 21, 2018

Legal Talk Network is excited to announce the legal and technology professionals that will be judging the Denver node of the Global Legal Hackathon. Where: Legal Talk Network located at 3120 Blake St. When: February 23-25. Denver, CO 80205. RiNo neighborhood). What: Solutions that improve the business of law.

Legal 40

Legal Legal Legal Technology Solution Technology 40

FDA Law Blog

MARCH 31, 2024

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chair Brett Guthrie (R-KY), in announcing the hearing, made their views clear: “FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input.

Sports 64

Sports Manufacturing Drafting Litigation 64

Strictly Business

DECEMBER 12, 2023

Therefore, the potential seller should aim to sign an NDA before disclosing any information to the potential buyer; however, if the parties do not, then the potential seller should draft the NDA to ensure that it protects information disclosed prior to the execution of the NDA. This article is for general information only.

Real Estate 80

Real Estate Finance Attorney Business Services 80

The IP Law Blog

JANUARY 26, 2023

101 is a threshold legal issue. Pursuant to 35 U.S.C § 101, “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Patentability under 35 U.S.C. §

Court 98

Court Technology Manufacturing Construction 98

Strictly Business

NOVEMBER 2, 2023

The LOI may also include an exclusivity period and very basic legal terms. The NDA is typically non-binding in terms of the commitment of either party to go forward with the transaction, but it does usually contain some legally binding provisions (such as confidentiality and exclusivity). This article is for general information only.

Diligence 78

Diligence Real Estate Legal Legal 78

Strictly Business

FEBRUARY 12, 2024

Overview The purchase agreement is the principal legal document used to effect a merger, acquisition, or sale transaction (an “M&A transaction”). The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship. corporations, limited liability companies, etc.),

Diligence 85

Diligence Real Estate Contract Business Services 85

Strictly Business

JANUARY 11, 2024

Even though some of the diligence requests relate to business points, the buyer’s deal counsel will typically lead the due diligence process because business points often overlap with legal points. The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship.

Diligence 84

Diligence Contract Document Review Real Estate 84

Broadcast Law Blog

FEBRUARY 27, 2023

At its March 16 regular monthly open meeting, the FCC will consider a draft Further Notice of Proposed Rulemaking (“FNPRM”) that, if adopted, would formally propose to extend the FCC’s existing audio description requirements for broadcast television to DMAs below the top 100 (i.e., DMAs 101-210).

Calendaring 97

Calendaring Manufacturing Drafting Contract 97

Customs & International Trade Law

APRIL 22, 2022

On April 15, 2022, the FDA published a draft guidance for industry on developing drugs to treat celiac disease, “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products. million, Italy at $72.54

Laws 90

Laws Manufacturing Administrative Law Drafting 90

The Estrin Report

OCTOBER 15, 2021

The legal field is known to be extremely competitive. For over 20 years, as a former senior legal officer for a Fortune 50 company, Sheila Murphy successfully developed, coached, and transformed talent in corporate America, and law firms. My AHA moment came when the company promoted a peer whose legal skills were lacking.

Lawyer 224

Lawyer Lawyers Laws Law Firm 224

ClimateChange-ClimateLaw

OCTOBER 16, 2023

produced steel, iron or manufactured products would increase the cost of the facility by more than 25 percent, or where such products “ are not produced in the United States in sufficient and reasonably available quantities or of a satisfactory quality ,” but actionable guidance from the IRS on this point has been limited.)

Government 132

Government Manufacturing Finance Drafting 132

ClimateChange-ClimateLaw

MARCH 29, 2024

This post is the third in a series of blogs that address specific legal features of the rule: Part One offered a summary of the final rule, and delved into the materiality threshold that was added throughout the rule, including for greenhouse gas (GHG) emissions disclosure. So: do the SEC or EPA reporting regimes preclude California’s laws?

Laws 66

Laws Government Drafting Manufacturing 66

FDA Law Blog

MARCH 20, 2022

The guidance defines a recall as a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the Agency would initiate legal action, e.g., seizure. Almost all recalls are conducted on a voluntary basis by the manufacturer.

Manufacturing 40

Manufacturing Drafting Legal Legal 40

The Fashion Law

OCTOBER 13, 2021

If the non-compete does amount to a restraint of trade, it must be “reasonable” in order to be legally enforceable. However, this highlights a critical issue with the drafting of non-competes. But employment agreements are not the only place where non-compete restrictions come into play.

Contract 55

Contract Drafting Manufacturing Laws 55

FDA Law Blog

SEPTEMBER 15, 2022

For both draft guidances, it is unclear what induced FDA to publish these draft guidances now. Draft Guidance Regarding the Statement of Identity and Strength for Human Nonprescription Drug Products.

Drafting 45

Drafting Manufacturing Healthcare Legal 45

FDA Law Blog

FEBRUARY 28, 2022

This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”.

Calendaring 52

Calendaring Healthcare Manufacturing Drafting 52

Conflict of Laws

SEPTEMBER 23, 2021

The core international conventions on cross-border cooperation (currently in force) were drafted many decades ago, when the overwhelming growth of ICTs was unimaginable. Remedies lie against the supplier or (where goods are supplied) against the manufacturer or both.

Laws 52

Laws Family Law Legal Legal 52

FDA Law Blog

NOVEMBER 14, 2022

2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. Livornese — Early Nov.

Drafting 52

Drafting Manufacturing Calendaring Laws 52

Patently O

SEPTEMBER 13, 2021

Most significantly, HTC was the developer and manufacturer of Google’s Nexus One Android phone , which was released in 2010. These standards are covered by tens of thousands of patents around the world (standards-essential patents or SEPs), a respectable number of which are held by Swedish equipment manufacturer Ericsson.

Contract 54

Contract Manufacturing Contract Law Court 54

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

Manufacturing 81

Manufacturing Healthcare Drafting Legal 81

Conflict of Laws

SEPTEMBER 21, 2023

– being primarily responsible for manufacturing and selling Huawei’s smart terminal products – was domiciled there. This legislative change provides a clear legal basis for Chinese courts to exercise jurisdiction over offshore cases, expands both the types of cases they can accept and their geographical reach.

Procedural Law 57

Procedural Law Laws Litigation Litigating 57

Patently O

JANUARY 12, 2023

In my book, The Genome Defense: Inside the Epic Legal Battle Over Who Owns Your DNA (New York: Algonquin, 2021), I discuss the Myriad case at length, focusing on its implications for human health and access to care.

Technology 89

Technology Litigation Litigating Manufacturing 89

Conflict of Laws

JANUARY 27, 2021

The following article primarily describes the legal situation in the judicial cooperation in civil and commercial matters from 1 January 2021. With the government draft of 25 September 2020, a comprehensive reform of guardianship and care law is approaching which will fundamentally modernize these areas. Schack: Does Art.

Construction 52

Construction Laws Court Government 52

Conflict of Laws

MAY 17, 2022

Since 2014 the American Law Institute2 now seeks to draft a new “Restatement” – the Third – of the subject, with the aim to clarify and perhaps to bring more uniformity to the resolution of conflict-of-laws problems. Examples drawn from existing drafts of new provisions may serve to venture some evaluation of these proposed changes.

Contract 40

Contract Legal Legal Court 40

Patently O

DECEMBER 28, 2022

One of the defendants (Amaxon) sells the accused product, but does not actually manufacture the product. Rather, Amaxon sells a product manufactured by Revloon. Crunch then used that Technical Report to draft an Opinion Letter stating that: “ Amaxon is infringing Dryson’s IP rights.” Should the court certify the class?

Laws 70

Laws Manufacturing Litigation Litigating 70

SCOTUSBlog

FEBRUARY 28, 2022

The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “[e]xcept as authorized by this subchapter.” Medicine, they contend, is by nature iterative, and the science of pain medicine in particular continues to evolve. (As

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Mens Rea Court Government Manufacturing 88