Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Jones Day Presents: Large Business & International Examination Strategies: Fast Track Settlements
On 1/15/25, the IRS announced three pilot programs to test changes to existing Alternative Dispute Resolution (ADR) programs. The new IRS Pilot Mediation Programs are designed to help taxpayers resolve tax disputes earlier...more
Taxpayers whose tax returns the IRS examines may experience long administrative delays in working with the IRS to resolve unagreed issues. About twenty years ago, the IRS developed a procedure – fast track settlement – to...more
On December 18, 2024, the U.S. Department of Homeland Security (DHS) will publish the long-awaited second portion of its H-1B modernization rule. The draft rule, which was originally published for notice and comment on...more
This session of the Private Client West Cost Forum 2024 explored the current state of audits and tax controversy and shared practical advice to prepare for challenges ahead of a contest with the IRS or Franchise Tax Board...more
On October 10, 2024, the U.S. Federal Trade Commission (“FTC”) voted 5-0 to adopt new Hart-Scott-Rodino (“HSR”) rules, which will substantially expand filing requirements for parties when the new rules go into effect. The...more
Governor Gavin Newsom has signed a controversial bill – Assembly Bill (AB) 98 – that will impact all warehouse developments, regardless of whether there are any sensitive receptors near the potential warehouse site....more
El 6/20/24, el IRS emitió el Consejo Fiscal 2024-59 para alertar a los contribuyentes que la mediación con el IRS puede ayudarlos a resolver sus problemas tributarios de manera temprana y efectiva. El IRS afirma que la...more
On 6/20/24, the IRS issued Tax Tip 2024-59 to alert taxpayers that mediation with the IRS can assist taxpayers to solve their tax issues early and effectively. IRS states that mediation with the IRS can be a more...more
The US Food and Drug Administration (FDA) recently announced its qualification of the Apple Atrial Fibrillation (AFib) History Feature through the Medical Device Development Tools (MDDT) program. The MDDT program is intended...more
Earlier this month, the National Advertising Division (NAD) of the Better Business Bureau (BBB) announced a recommendation that Planting Hope Brands, LLC discontinue use of the ® (registered trademark symbol) in advertising a...more
Effective March 1, 2024, the American Arbitration Association (the AAA) adopted an updated version of its Construction Industry Arbitration Rules and Mediation Procedures (the Rules), for the first time since 2015. The Rules...more
The Background: On November 15, 2023, the Temporary Fast-Track Liquidation Transparency Act (Tijdelijke Wet Transparantie Turboliquidatie) (the "Act") came into force in the Netherlands, temporarily changing certain statutory...more
A new program offers rulings in 12 weeks, even absent a showing of business need. Revenue Procedure 2023-26, issued July 26, 2023, in replacement of a popular 18-month pilot program under Revenue Procedure 2022-10,...more
On July 26, 2023, the Internal Revenue Service (IRS) Chief Counsel’s Office announced that it would make permanent its pilot program of issuing “fast-track” private letter rulings for requests solely or primarily under the...more
As part of this program, our presenter will share best practices for resolving technology disputes through arbitration and mediation and will also review provisions that should be included in an arbitration clause or an...more
On February 1, 2023, the United States Patent & Trademark Office (USPTO) will begin accepting petitions to accelerate examination under the Cancer Moonshot Expedited Examination Pilot Program (the “Moonshot Program”). The...more
The Cancer Moonshot Expedited Examination Pilot Program (the new Pilot) will accord special status (earlier examination) to patent applications directed to technologies to prevent cancer and cancer mortality. The new Pilot...more
The Commission de Surveillance du Secteur Financier (CSSF), the Luxembourg financial services regulator, on 27 July 2022 issued a communication to the investment fund industry reminding it of the deadline of 1 January 2023...more
On June 29, 2022, the United States Patent & Trademark Office (USPTO) announced that it was temporarily extending its Cancer Immunotherapy Pilot Program (”Patents 4 Patients” or “P4P”) to September 30, 2022, and also issued a...more
Yesterday, a notice was published in the Federal Register announcing yet another extension of the U.S. Patent and Trademark Office (USPTO) pilot program for expedited review of COVID-19-associated patent applications (the...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more
In a notice published last week in the Federal Register (87 Fed. Reg. 33750), the U.S. Patent and Trademark Office announced the implementation of the Climate Change Mitigation Pilot Program, "which is designed to positively...more
The USPTO now fast tracks applications involving greenhouse gas reduction technologies. The new Climate Change Mitigation Pilot Program targets impact on the climate by accelerating examination of patent applications for...more
Corporate reorganizations and spin-off transactions are transactions where there is often a great deal of incentive to qualify for tax-free treatment. In many cases, the amount of tax at issue justifies obtaining a private...more
The IRS in January released Rev. Proc. 2022-10, which establishes an 18-month pilot program to provide for fast-track processing of certain private letter ruling (PLR) requests solely or primarily under the jurisdiction of...more