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Federal Register — Trade & Customs

Rules, proposed rules, and notices from CBP, USTR, Commerce ITA, USITC, and BIS affecting tariffs, trade remedies, anti-dumping duties, and customs regulations.

Notice2026-066612026-04-06

Determination That STRATTERA (Atomoxetine Hydrochloride) Capsules 5 Milligrams, 10 Milligrams, 18 Milligrams, 25 Milligrams, 40 Milligrams, 60 Milligrams, 80 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Rule2026-043682026-03-05

Revising the National Drug Code Format and Drug Label Barcode Requirements

Health and Human Services Department, Food and Drug Administration

Notice2026-041962026-03-03

Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments

Health and Human Services Department, Food and Drug Administration

Proposed Rule2025-237052025-12-23

Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

Health and Human Services Department, Centers for Medicare & Medicaid Services

Proposed Rule2025-237022025-12-23

Global Benchmark for Efficient Drug Pricing (GLOBE) Model

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2025-226812025-12-12

Determination That DEMEROL (Meperidine Hydrochloride) Tablet, 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Rule2025-209072025-11-25

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots

Health and Human Services Department, Centers for Medicare & Medicaid Services,

Rule2025-197872025-11-05

Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2025-150822025-08-08

Product-Specific Guidance on Iron Sucrose; Draft Guidance for Industry; Availability

Health and Human Services Department, Food and Drug Administration

Notice2025-144112025-07-30

Generic Drug User Fee Rates for Fiscal Year 2026

Health and Human Services Department, Food and Drug Administration

Proposed Rule2025-133602025-07-17

Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency

Health and Human Services Department, Centers for Medicare & Medicaid Services,

Proposed Rule2025-132712025-07-16

Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2025-116052025-06-25

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program

Health and Human Services Department, Food and Drug Administration

Notice2025-011512025-01-17

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Experience Reporting

Health and Human Services Department, Food and Drug Administration

Notice2025-011492025-01-17

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program

Health and Human Services Department, Food and Drug Administration

Rule2024-302612024-12-26

Nonprescription Drug Product With an Additional Condition for Nonprescription Use

Health and Human Services Department, Food and Drug Administration

Rule2024-253822024-12-09

Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2024-284332024-12-05

Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Rule2024-212542024-09-26

Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program

Health and Human Services Department, Centers for Medicare & Medicaid Services

Notice2024-216752024-09-23

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

Health and Human Services Department, Food and Drug Administration

Proposed Rule2024-206022024-09-16

Phasedown of Hydrofluorocarbons: Review and Renewal of Eligibility for Application-Specific Allowances

Environmental Protection Agency

Notice2024-168962024-07-31

Generic Drug User Fee Rates for Fiscal Year 2025

Health and Human Services Department, Food and Drug Administration

Proposed Rule2024-148282024-07-31

Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments

Health and Human Services Department, Centers for Medicare & Medicaid Services

Rule2024-131902024-06-18

Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases

Health and Human Services Department, Food and Drug Administration

Notice2024-074942024-04-09

Determination That NALFON (Fenoprofen Calcium) Oral Capsules, Equivalent to 300 Milligram Base, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

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