Pharmaceutical Policy

Drug approval, safety, pricing, and FDA drug/biologic rules.

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July 2026

Legislation

Bill reported · Jul 28Reported

Medication Affordability and Patent Integrity Act

Bill reported · Jul 28Reported

Medication Affordability and Patent Integrity Act

Rulemaking

Comment period closing · Food and Drug Administration · Jul 27FDAClosed

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Notice · Food and Drug Administration · Jul 27FDA

Citizen Petition from End Kratom Addiction

Notice · Food and Drug Administration · Jul 27FDA

Completeness Assessment Correspondence to Senores Pharmaceuticals, Inc.

Legislation

Bill reported · Jul 27Reported

Expedited Access to Biosimilars Act

Bill reported · Jul 27Reported

Expedited Access to Biosimilars Act

Bill reported · Jul 27Reported

Patients Deserve Price Tags Act

Bill reported · Jul 27Reported

Patients Deserve Price Tags Act

Bill reported · Jul 27Reported

SAFE Drugs Act of 2026

Bill reported · Jul 27Reported

SAFE Drugs Act of 2026

Bill reported · Jul 27Reported

Biosimilar Red Tape Elimination Act

Bill reported · Jul 27Reported

Biosimilar Red Tape Elimination Act

Rulemaking

Comment period closing · Food and Drug Administration · Jul 26FDAClosed

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)

Comment period closing · Food and Drug Administration · Jul 26FDAClosed

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec

Comment period closing · Food and Drug Administration · Jul 25FDAClosed

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products

Comment period closing · Department of Health and Human Services · Jul 25HHSClosed

OASH Request for Information Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I

Comment period closing · Food and Drug Administration · Jul 25FDAClosed

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

Comment period closed · Food and Drug Administration · Jul 25FDAClosed

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability

Comment period closed · Food and Drug Administration · Jul 25FDAClosed

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance

Upcoming deadlines

Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV

FDA · Comment closes · Aug 29

Determination of Regulatory Review Period for Purposes of Patent Extension; VYALEV

FDA · Comment closes · Aug 29

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Virus-Serum-Toxin Act and Regulations

APHIS · Comment closes · Sep 1

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry

FDA · Comment closes · Sep 2

Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements

FDA · Comment closes · Sep 5

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