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Administrative Procedure Act

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

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The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

Fisher Phillips

New California Regs Will Impact Your AI and Privacy Policies: FAQs on Automated Decision-Making, Risk Assessments, and...

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California regulators unanimously approved a sweeping set of regulations on July 24 governing the use of automated decision-making technology (ADMT) and mandating risk assessments and cybersecurity audits for businesses...more

Foley & Lardner LLP

Patent Fees Reimagined: Evaluating the Trump Administration's Value-Driven Fee Structure and Its Impact on Innovators

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The WSJ reports the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee...more

Latham & Watkins LLP

California Low Carbon Fuel Standard Amendments Take Effect

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On June 27, 2025, the California Office of Administrative Law (OAL) approved the amended Low Carbon Fuel Standard (LCFS) Regulation, submitted by the California Air Resources Board (CARB) to the OAL on May 16, 2025....more

Pillsbury Winthrop Shaw Pittman LLP

Streamline, Simplify, Deregulate: The FCC Adopts “Direct Final Rule” Approach to Expedite Rule Deletions

Earlier this year, Federal Communications Commission (FCC) Chairman Brendan Carr initiated a sweeping initiative to review “every rule, regulation, or guidance document” that could be eliminated “for the purposes of...more

Wyrick Robbins Yates & Ponton LLP

U.S. District Court Vacates HIPAA Reproductive Health Privacy Rule Nationwide

A U.S. District Court in the Northern District of Texas has vacated most of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (the “Rule”) in the case of Purl v. DHHS. The ruling, which has immediate...more

Downs Rachlin Martin PLLC

Captive Insurance Update | Issue 2 | 2025

Every year, the members of the Vermont Captive Insurance Association’s legislative committee and the Vermont Department of Financial Regulation (the “DFR”) work to improve Vermont’s captive insurance laws and regulations....more

Husch Blackwell LLP

Federal Court Vacates 2024 HIPAA Reproductive Health Privacy Rule: Key Impacts for Covered Entities and NPP Compliance

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On June 18, 2025, the U.S. District Court for the Northern District of Texas issued a decision in Carmen Purl, et al. v. United States Department of Health and Human Services, et al., vacating nearly all of the 2024 HIPAA...more

Holland & Hart LLP

Nevada Legislature Enhances Notice-and-Comment Requirements Under the Nevada Administrative Procedure Act

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Starting October 1, 2025, Nevada businesses will have expanded opportunities to receive advance notice of proposed regulations that could affect their operations. AB 444 requires state agencies to proactively notify...more

Holland & Knight LLP

Post-Termination Landscape for Department of Energy Grant Projects

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Following the U.S. Department of Energy's (DOE) announcement of a new project review process in May 2025, the Office of Clean Energy Demonstrations (OCED) issued the first round of DOE grant terminations under the Trump...more

Warner Norcross + Judd

TPS in Transition: Litigation, Terminations and Temporary Protections in Flux

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Temporary Protected Status (TPS) allows eligible foreign nationals to enter and remain in the U.S. for a limited period due to extraordinary conditions in their home countries, such as natural disasters or armed conflicts....more

Ballard Spahr LLP

Community Groups File Lawsuit Seeking to Force CFPB to Implement the Section 1071 Rule

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The saga of the CFPB’s section 1071 small business data collection and reporting rule continues. Rise Economy, fka California Reinvestment Coalition (Rise), the National Reinvestment Coalition (NCRC), the Main Street Alliance...more

Wiley Rein LLP

Federal Court Vacates Portions of Local Television Ownership Rule

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On July 23, 2025, the U.S. Court of Appeals for the Eighth Circuit vacated two aspects of the Federal Communications Commission’s (FCC or Commission) regulation restricting the number of television stations that one entity...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

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In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

Fox Rothschild LLP

Court Vacates CFPB Medical Debt Rule: Key Takeaways for Providers

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Earlier this month, the United States District Court for the Eastern District of Texas approved a consent judgment vacating the Consumer Financial Protection Bureau’s (CFPB) Medical Debt Rule. The decision holds that the CFPB...more

Husch Blackwell LLP

Will Trump v. CASA Lead to Increased State AG Multistate Investigations and Litigation?

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On June 27, 2025, in its long-anticipated decision in Trump v. CASA, Inc., the U.S. Supreme Court significantly narrowed the ability of a single federal court to issue “universal” or “nationwide” injunctions—through which...more

Ballard Spahr LLP

Eighth Circuit voids FTC ‘Click to Cancel’ rule

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A federal appeals court has nullified the Federal Trade Commission’s amendments to its Negative Option Rule intended to make it easier for people to cancel subscriptions....more

Jackson Lewis P.C.

Mid-Year 2025

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The last six months have been a tumultuous time for employers. The pace and degree of change is creating new challenges — and ongoing uncertainty. Our Mid-Year 2025 report sifts through the volume of federal-level executive...more

Offit Kurman

Quick Guide to Administrative Hearings

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Join the Litigators Lounge with Offit Kurman’s Anders Sleight and Niall McMillan as they dive into the nuances of administrative proceedings versus typical civil court cases, focusing on the process, discovery limitations,...more

Jones Day

“Settled-Expectations” Analysis May Leave Some Petitioners Feeling Unsettled

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As discretionary denials are on the rise and institution rates are declining at the PTAB (link), recent decisions from the PTAB have introduced the notion of a patent owner’s “settled expectations” as another reason for the...more

Perkins Coie

Failure to Explain Selection of Project Alternative Violated NEPA and APA

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The Ninth Circuit held that the Bureau of Land Management (BLM) acted arbitrarily and capriciously by failing to explain in its Record of Decision why it selected a project alternative that did not meet the development...more

Womble Bond Dickinson

FCC Repeals One-to-One Consent Rule Following Eleventh Circuit Decision

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Following a January 2025 decision by the Eleventh Circuit Court, the Federal Communications Commission (FCC or Commission) has repealed its one-to-one consent rule for prior express written consent, consistent with its...more

Beveridge & Diamond PC

Coalition of US States and Cities Lays Groundwork for Legal Challenge of the Department of Energy’s Appliance Efficiency Rollback

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A multistate coalition of twelve state Attorneys General—California, Connecticut, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Vermont, and Washington—joined by the District of...more

Hogan Lovells

FDA Proposes Revoking Standards of Identity for 52 Food Products

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On July 16, 2025, the U.S. Food and Drug Administration (FDA) announced plans to revoke the standards of identity for 52 food products the agency characterizes as obsolete. To do this, FDA has issued three proposed rules and...more

Stevens & Lee

FTC Requests Additional 60 Days to Consider Dropping Defense of Noncompete Ban

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A reconstituted Federal Trade Commission (Commission) has asked the Fifth Circuit Court of Appeals to grant it a 60-day continuance to consider whether to drop the defense of its rule banning noncompetes. As previously...more

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