The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AURORA EV-ICD and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV-ICD”

The Food and Drug Administration (FDA) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day commen

Original title: “Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments”

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Original title: “Submission for OMB Review; 30-Day Comment Request; Regular Clearance for Autism Spectrum Disorder (ASD) Research Portfolio Analysis (National Institute of Mental Health)”

The Office of Grants Management (OGM), in the Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-OGM-SF-PPR-B (Office of Management and Budget (OMB) #0970- 0406, expiration 1/31/2026). There are minor changes proposed to this form to align with the requirements in 2 CFR 200.329 and reduce recipient burden by reducing the number of questions on the form. Additionally, the number of respondents has been reduced based on program office feedback.

Original title: “Submission for Office of Management and Budget Review; ACF Performance Progress Report, ACF-OGM-SF-PPR-B”

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services seeks Office of Management and Budget (OMB) approval for a 3- year extension to the existing data collection for the ORR-6 Performance Report forms (OMB #0970-0036, expiration December 31, 2025) with minor changes to the instructions. The minor proposed changes removed parts of the instructions that are no longer relevant due to expired program funding and clarif

Original title: “Submission for Office of Management and Budget Review; ORR-6 Performance Report”

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.

Original title: “New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address”

Legislative sessions are underway in most states, and some have introduced novel legislation to regulate compounded medications, including those specific to weight loss.

Original title: “State Compounding Legislation: Federal Preemption, State Limits and Patient Impact | Skadden, Arps, Slate, Meagher & Flom LLP - JDSupra”

The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.

Original title: “TrumpRx Website Set To Launch Thursday Evening After Delay”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 735: Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2025”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 1796: Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2025”

Read twice and referred to the Committee on Finance.

Original title: “S 882: Patients Before Middlemen Act”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.”

Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 2450: Prescription Drug Transparency and Affordability Act”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 1302: Increasing Transparency in Generic Drug Applications Act”

Received in the Senate and Read twice and referred to the Committee on Finance.

Original title: “HR 4313: Hospital Inpatient Services Modernization Act”

Read twice and referred to the Committee on Finance.

Original title: “S 2237: Hospital Inpatient Services Modernization Act”

Placed on Senate Legislative Calendar under General Orders. Calendar No. 140.

Original title: “S 2587: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026”

Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 5281: REAL Health Providers Act”

Placed on the Union Calendar, Calendar No. 227.

Original title: “HR 5304: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026”

Policy strategist Kristi Martin discusses how the Orphan Drug Act reshapes rare disease treatment and drug-pricing challenges. In this episode, Kristi Martin, a longtime Washington, DC–based policy strategist with deep experience implementing major legislation like the Affordable Care Act and the Inflation Reduction Act, explores how the Orphan Drug Act, passed in 1983 as a bipartisan, patient-driven effort, transformed · rare disease treatment by aligning scientific advances, government investment, and market incentives. equity challenges as the Orphan Drug Act intersects with modern drug pricing policy, including the shielding of high-spending orphan oncology drugs from negotiation. While acknowledging the law’s life-saving impact, Martin argues that reform may now be necessary—rethinking incentives for blockbuster drugs, refining orphan drug eligibility, and shifting toward more targeted, evidence-based negotiation—while emphasizing the federal government’s continued role in sustaining innovation through agencies such as the NIH, FDA, and CMS.

Original title: “The Orphan Drug Act in the Modern Drug Pricing Era | AJMC”