Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Jones Day Presents: Large Business & International Examination Strategies: Fast Track Settlements
Some disputes do not warrant a lengthy and costly dispute resolution process. That is particularly the case where the issues in dispute or the facts of the matter are straightforward. Consequently, many of the leading...more
On Oct. 27, 2025, the U.S. Patent and Trademark Office (USPTO) announced it is offering a Streamlined Claim Set Pilot Program in an effort to further accelerate examination of currently pending applications with a limited...more
On November 25, 2025, FERC accepted the Midcontinent Independent System Operator, Inc.’s (MISO) proposal to expand the number of interconnection requests MISO may study under its temporary, fast-tracked generator...more
On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of...more
New York City voters ushered in sweeping changes to land use policy in the November mayoral election, approving four major City Charter amendments recommended by the Charter Revision Commission convened by Mayor Eric Adams in...more
FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene therapies (“CGTs”):...more
The Internal Revenue Service ("IRS") is doubling down on its primary alternative dispute resolution ("ADR") tools. It is clear that the IRS wants taxpayers to resolve their disputes prior to going to court....more
On October 8, Maryland Securities Commissioner Melanie Senter Lubin announced a Fast-Track Program, launching January 1, to expedite franchise renewal registrations. The program will benefit franchisors, franchisees, and the...more
On September 23, 2025, the FDA published three new draft guidances that give insight into a regulatory framework for cell and gene therapies (CGTs) that is now coming into focus. By releasing these guidances together, FDA is...more
Despite geopolitical unpredictability, including proceeding into an in-depth investigation against Nvidia for potential remedy compliance violations in the wake of the U.S.-China trade negotiations in Madrid, China has...more
Over the past few months, interest and attention in the world of U.S. tax has been focused on the OBBBA — the One Big Beautiful Bill Act. However, significant administrative and procedural changes have also occurred at the...more
The IRS Large Business & International (LB&I) Division published an Interim Guidance Memorandum (IGM) on July 23, 2025, implementing three changes to current LB&I audit procedures. Specifically, the IGM (1) removes the...more
Tax developments - IRS issues interim guidance to streamline LB&I audit procedures and promote alternative settlement programs - Significant updates from the IRS Large Business & International (LB&I) Division will take...more
In May 2025, the Treasury Department, as chair of the Committee on Foreign Investment in the United States (CFIUS), announced a new “fast track process to facilitate greater investment in U.S. businesses from ally and partner...more
Effective July 8, 2025, the U.S. Patent and Trademark Office (USPTO) expanded the availability of prioritized examination, increasing the limit on the number of requests from 15,000 to 20,000 in a fiscal year. The 20,000...more
The Department of Defense (DoD) is revving its engines again—this time to rocket past its own software acquisition drag. Launched via an April 24 memo from Acting DoD CIO Katie Arrington, the DoD’s Software Fast Track (SWFT)...more
The U.S. Department of the Treasury on May 8, 2025, announced its intent to launch a fast-track process to facilitate greater investment from allied and partner sources. The process will include the launch of a "Known...more
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