Pharmaceutical Policy

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

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August 2026

Rulemaking

Comment period closing · Drug Enforcement Administration · Aug 1DEAClosed

Schedules of Controlled Substances: Placement of Tianeptine in Schedule I

Comment period closing · Food and Drug Administration · Aug 1FDAClosed

Medical Device User Fee Amendments; Public Meeting; Request for Comments

Comment period closed · Food and Drug Administration · Aug 1FDAClosed

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

Comment period closed · Food and Drug Administration · Aug 1FDAClosed

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Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

Comment period closed · Department of Health and Human Services · Aug 1HHSClosed

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

July 2026

Rulemaking

Comment period closing · Food and Drug Administration · Jul 31FDAClosed

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 31HHSClosed

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

Comment period closing · Food and Drug Administration · Jul 31FDAClosed

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Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

Notice · Food and Drug Administration · Jul 31FDA

Attachment 3 - Draft Package Insert Proposed for Meropenem for Injection and Sodium Chloride Injection 2 g/ Dual-Mix® container.

Notice · Food and Drug Administration · Jul 31FDA

Attachment 2 - Current Package Insert for Meropenem for Injection and Sodium Chloride Injection, 1 g/Duplex container, Revision 12/2024; source: Drugs@FDA

Notice · Food and Drug Administration · Jul 31FDA

Attachment 1 - Copy of the relevant excerpt from the current electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Notice · Food and Drug Administration · Jul 31FDA

Acknowledgment Letter from FDA DMB to Lachman Consulting Services, Inc.

Notice · Food and Drug Administration · Jul 31FDA

Suitability Petition from Lachman Consulting Services, Inc.

Comment period closed · Drug Enforcement Administration · Jul 31DEAClosed

Comment period closed · Drug Enforcement Administration · Jul 31DEAClosed

Comment period closed · Food and Drug Administration · Jul 31FDAClosed

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Comment period closing · Drug Enforcement Administration · Jul 30DEAClosed

Comment period closing · Drug Enforcement Administration · Jul 30DEAClosed

Comment period closing · Food and Drug Administration · Jul 30FDAClosed

List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Comment period closing · Food and Drug Administration · Jul 30FDAClosed

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

Upcoming deadlines

Collection Requirements for Compendia for Determination of Medically-accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen (CMS-10302)

CMS · Comment closes · Aug 11

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

FDA · Comment closes · Aug 13

Development of 21st Century Cures Act Section 3060 Required Report: Request for Input

FDA · Comment closes · Aug 14

Request for Information: Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies in Ambulatory Clinical Settings

HRSA · Comment closes · Aug 14

DEA · Comment closes · Aug 15

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