This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate.
Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.
Sometimes when a lawyer calls in, there is a despondency in the voice that comes across loud and clear. The lawyer isn’t always aware of it; but usually by the time the call ends, that has changed. As I see it, since that’s what was driving the despondency, life is too short to stay in the game. ABA Model Rule 1.16
While good stuff, I suspect many attorney departures occur without anyone ever taking the time to pick up one of these books, if for no other reason than the lack of time. At all times, keep the interests of all impacted clients first and foremost in mind when making any departure-related decisions.
Whenit comes to problem clients, we all have a story or two to share; but what if it becomes more than that? It can happen, and if and whenit does, it’stime to stop and do a little problem solving. It’stime to look for the learning. It’stime to look for the learning.
This is an atypical situation in the Brazilian context: having a full day focused on environmental cases has never been done before, and emphasizes the deliberate effort of the Supreme Court to ensure an environmental agenda within the country. Brazill (on Amazon Fund) (ADO 59).
Chanel Files for the Number 5, Prada Pairs Down its Triangle. As we noted earlier this month, Chanel is aiming to bolster its robust arsenal of world-famous trademark registrations by way of an interesting mark. Huawei Prevails in the Trademark Case Waged Against it by Chanel. and internationally that are worth reflecting on.
Harmless enough… next it is a question regarding case strategy which you thought had been clearly understood and agreed to months earlier… then an adverse decision comes out and everything you have done on the case is in question!!! At first, the red flag might be subtle; the client has a question regarding your invoice. What should you do??
It would be pretty radical right? It promotes a culture based on honesty, communication, and, ultimately, everyone knowing everything … all the time. This was certainly the case for Dalio whose focus on transparency can be in his concepts of: Radical truth – The prioritization and focus on the utter truth at all times.
After considering Gray’s response to the NAL, the FCC elected not to cancel, withdraw, or reduce the penalty proposed. The FCC issued the final text of its Notice of Inquiry and Order that explores opportunities to open the 12.7-13.25 The FCC issued a Forfeiture Order imposing a penalty of $518,283 against Gray Television, Inc.,
On 21 May 2024, the International Tribunal for the Law of the Sea (ITLOS) delivered its much anticipated Advisory Opinion on Climate Change. Points of Entry of External Rules ITLOS devotes Section V of its Advisory Opinion to ‘Interpretation of the Convention and the relationship between the Convention and external rules’ (paras.
This blog post is in partnership with LMG Security. In this article, we’ll discuss how criminals use stolen data, and provide practical tips for reducing risk when—not if—sensitive information is leaked to the world. We’re also hosting a CLE Cybersecurity Academy with LMG Security on October 19 and November 9. The good news?
It has been used as an honorary designation for retired partners, a special designation for firm attorneys who are neither a partner nor an associate, and to describe part-time attorneys who have created an association with a firm. The term “of counsel” has multiple meanings. What is an of counsel attorney?
It has spread, perhaps most notably to the Southern District of Florida and the Southern District of New York. When the plaintiff moved to extend the TRO, multiple defendants appeared to object. But Schedule A litigation is not confined to Chicago. One recent decision out of New York merits closer attention. for Hyponix and $14,641.51
Livornese — With the new Over-the-Counter (OTC) Monograph Reform came new facility fees (see our blog posts here and here , and FDA’s announcement here ), and with new fees comes the new Arrears List. Facility fees under the OTC Monograph User Fee Act (OMUFA) were due for the first time on May 10, 2021, for fiscal year (FY) 2021.
The RMLC suit is premised on the concept that any time multiple products from independent marketplace competitors (in this case the songs of multiple songwriters) are packaged together and sold at an all or nothing price, there is the potential for obtaining prices higher than would be obtained on the open market.
Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. It does so by amending FDC Act § 505(q), the current statutory subsection regarding citizen petitions.
For many law firms, getting paid promptly can be a challenge because clients aren’t always prepared to retain an attorney when an unexpected legal matter arises. 21st-century payment processing tools make it easier than ever to collect legal fees. How Do Online Payments Benefit My Firm? . Offer Payment Links .
Especially in the international practice of collective actions, TPLF has gained popularity for its ability to provide the financial means needed for these typically complex and very costly procedures. This makes it an appealing prospect for funders who may be interested in investing with the possibility of sharing in these proceeds.
Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). Well, we found much more than we thought we would. But all kidding aside, some of the recent decisions we found are rather distressing.
2] Courtesy of these leniency programs, the Division and its global counterparts have worked to dismantle some of the most sophisticated international cartels and recover billions of dollars in criminal fines. [3] 43 However, the one-stop-shop gives rise to its own enforcement challenges. [44] 1] To deter cartel activity, the U.S.
Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). That said, the guidance will be a helpful reference for companies that are not sure whether they are subject to the OMUFA facility fees, whether there any exceptions, how much they have to pay, when they need to pay, etc.
The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order. Rather than modify the existing FDR guidance and issue separate guidance on consolidated proceedings, FDA has issued a single draft guidance covering both topics.
Commercial radio broadcasters have been seeing numerous communications over the last week about Global Music Rights (GMR) and its seemingly contentious music royalty negotiations with the Radio Music License Committee (RMLC). Many stations are confused about this controversy and what it is all about.
Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. The link to Part 1 is here. Investigator Preparation .
Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. The link to Part 1 is here. Investigator Preparation . 1316.05.
By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).
I’ve done a fair amount of cycling over the years and it’s a way I stay in shape and so enjoyed it, particularly in 2020 when we had the shutdown. That summer I put in, I think it was over 2,200 miles. It was just an interesting, interesting story, or I should say, interesting experience.
3] For the first time since the withdrawal of the United Kingdom from the European Union (so-called Brexit ) on 31 January 2020, a general multilateral instrument would thus once again be put in place to govern the mutual recognition and enforcement of judgments in civil and commercial matters across the English Channel.
We blogged on the final 2016 guideline here on March 17, 2016). Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We On February 10th, the agency published a comprehensive proposal to update the guideline.
Not taking into consideration the financial, labor, and time resources required to replace a single employee, what would it cost to lose 1/4th of your workforce right now? That 25% is spread across companies and industries but it drives the point home. They won’t be satisfied with the same day-to-day routine all the time.
Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. By Larry K.
And be aware that when adopting this rule, some states went a bit further and altered the language found in MRPC 1.6(b)(1) The lawyer’s concern must be specific and, if not imminent, reasonably certain to come to pass in the future if action isn’t taken to prevent it. Stories such as these are not one-offs. Consider MRPC 1.6 (b)(1)
We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. 105288 (Dec. The third was the postmarketing requirement for reporting an ACNU failure.
We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule.
If you are the importer of record, it is your duty to exercise reasonable care in meeting these obligations. When importing drones into the U.S., Classification When importing goods into the United States, importers must correctly classify their products. requires navigating a web of regulations that spans 47 federal agencies.
If so, the media will continue to speed along its own demise with many seeking their news from new media. If so, the media will continue to speed along its own demise with many seeking their news from new media. It says a great deal about the state of modern journalism and its unrelenting efforts at self-destruction.
Once upon a time, the word “canceled” was only applicable to objects and things. It’s no longer objects and things that get canceled, but people and companies too. But it’s ultimately their actions, statements, or sentiments that led them to be canceled by the internet-at-large. What is cancel culture?
The law grants broad powers to the President to control economic transactions, although it does not mention tariffs specifically. Under his America First Trade Policy , President Trump has made clear that his Administration intends to use every tool available to address unfair trade practices affecting U.S.
This post is the first of a new Climate Law Blog series, 100 Days of Trump 2.0 , in which the Sabin Center offers reflections on the first hundred days of President Trumps second term across a variety of climate-related topics. To read other posts from the series, which will roll out over the course of the next week, click here.
This blog post highlights aspects of the EOs of particular interest to cities, other local governments, and community based organizations (CBOs). It does not seek to discuss every aspect of Trumps EOs, nor to answer every question about the lawfulness of various provisions, nor to set out the exact mechanics for whats to come.
Mark Skrobola (MCS@flickr), CC BY 2.0 , via Wikimedia Commons On Friday President Trump fulfilled a campaign promise and signed an executive order (EO) that directs agencies to identify 10 existing rules, regulations, or guidance documents to repeal for each new rule, regulation, or guidance that an agency promulgates. The Sabin Centers U.S.
This post is part of a new Climate Law Blog series, 100 Days of Trump 2.0 , in which the Sabin Center offers reflections on the first 100 days of President Trumps second term across a variety of climate-related topics. To read other posts from the series, which will roll out over the course of this week, click here.
Each month, Arnold & Porter and the Sabin Center for Climate Change Law collect and summarize developments in climate-related litigation, which we also add to our U.S. and non-U.S. climate litigation charts. If you know of any cases we have missed, please email us at columbiaclimate@gmail.com. FEATURED CASE.
We organize all of the trending information in your field so you don't have to. Join 99,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content