US FDA guidance for industry April – June 2026

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
13 May 2026Development of Non-Opioid Analgesics for Acute PainDraft, Level 2This guidance is written in response to the statutory requirements of section 3001(b) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which directs FDA to issue or update existing guidance to help address challenges to developing nonaddictive medical products to manage pain.
In keeping with the mandate of section 3001(b), and considering the severity of the ongoing opioid crisis, this guidance is also intended to assist sponsors in the development of alternatives to opioids for the management of acute pain. Accordingly, this guidance addresses FDA’s current thinking about three specific topics: development of non opioid analgesic products for acute pain, labeling claims, and expedited programs as they pertain to this purpose.

This guidance does not address the management of chronic pain, which will be the focus of a future guidance. This guidance also does not address the development of opioid products.
13 May 2026Development of Local Anesthetic Drug Products With Prolonged Duration of EffectDraft, level 2 revisedThe purpose of this guidance is to assist sponsors that are developing local anesthetic drug products to produce postoperative analgesia for a prolonged duration, for which submission of an NDA through the pathway described in section 505(b) of the FD&C Act is appropriate. This guidance is not applicable to applications that meet criteria for submission under section 505(j) of the FD&C Act, petitioned abbreviated new drug applications under section 505(j)(2)(C) of the FD&C Act, or applications submitted under section 351 of the PHS Act.
12 May 2026Stimulant Use Disorders: Developing Drugs for TreatmentThe purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. Specifically, this guidance addresses the FDA’s current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications for treatment of moderate to severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant
use disorder.
This draft guidance is intended to serve as a focus for continued discussions among CDER staff (particularly the Division of Anesthesiology, Addiction Medicine, and Pain Medicine, or the division), pharmaceutical sponsors, the academic community, and the public.
This guidance does not address treatment of intoxication or poisoning with various stimulants or treatment of withdrawal from stimulants.
12 May 2026Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for IndustryDraft, Level 2 RevisedThe purpose of this guidance is to describe the benefit-risk assessment framework that the Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for approval under section 505 of the Federal Food, Drug, and Cosmetic Act. This guidance summarizes the information that should be included in a new drug application for an opioid analgesic drug to facilitate the Agency’s benefit-risk assessment.
12 May 2026Development of Non-Opioid Analgesics for Chronic PainDraft, Level 2 revisedFDA is committed to using its authorities to combat the opioid crisis. This guidance is intended to address two Agency priorities: (1) fostering the development of novel analgesic products and (2) decreasing opioid analgesic exposure and preventing new addiction.

This guidance also responds to the statutory requirements of section 3001(b) of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which directs FDA to issue or update existing guidance to help address challenges to developing non-opioid medical products to treat pain.

In keeping with the mandate of section 3001(b) of the SUPPORT Act, and considering the severity of the ongoing opioid crisis, this guidance is intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain.
8 May 2026Postapproval Pregnancy Safety StudiesFinal, Level 1The purpose of this guidance is to provide sponsors and investigators with recommendations on how to design investigations to assess the safety outcomes of pregnancies in women who are exposed to FDA regulated drug and biological products during pregnancy (i.e., pregnancy safety studies) in the postmarketing setting. The goal of postapproval pregnancy safety studies is to provide clinically relevant human safety data that can inform health care providers treating or counseling patients who are pregnant or anticipating pregnancy about the safety of drugs by
including the information in the Pregnancy subsection and other relevant sections of labeling.
Clinical information needed to support a specific indication or comparative claims in pregnant women is outside the scope of this guidance.
7 May 2026Submitting Continuous Glucose Monitoring Data in Clinical TrialsFinal, Level 2This document provides technical specifications for submitting continuous glucose monitoring
(CGM) data in clinical trials to support a marketing application for a drug or biological product.
17 Apr 2026Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersLevel 1 RevisedThis guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access
to investigational drugs for treatment use under an IND (21 CFR part 312, subpart I), which went into effect on October 13, 2009.
17 Apr 2026Establishing Impurity Specifications for AntibioticsDraft, Level 1This guidance provides recommendations to industry for establishing specifications for impurities in antibiotics manufactured by fermentation and semi-synthesis. These recommendations can be used to establish consistent standards for impurity testing and ensure that batches of antibiotic drug products meet appropriate impurity specifications. This guidance applies to antibiotic drugs, including:

• Antibiotic drugs subject to approval under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted under section 505 of the Federal FD&C Act (21 U.S.C. 355) and associated type II drug substance drug master files (DMFs) referenced in NDAs and ANDAs for antibiotic products

• Nonprescription antibiotic drugs marketed under section 505G of the FD&C Act, often referred to as over the-counter (OTC) monograph drugs.
15 Apr 2026Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation SequencingDraftThis guidance provides recommendations for next-generation sequencing (NGS)-based methods used in nonclinical studies that will likely be needed to support initiation of clinical trials of investigational human genome editing (GE) products.
10 Apr 2026Bioanalytical Method Validation for BiomarkersFinal, Level 2This guidance helps sponsors of INDs and applicants of NDAs, BLAs, and NDA and BLA supplements as well as ANDAs, as applicable, to validate bioanalytical methods used to evaluate biomarker concentrations. This guidance can also
inform the development of bioanalytical methods used for the analysis of biomarker concentrations in nonclinical study samples.

The recommendations in this guidance pertain only to the validation of bioanalytical assays to measure in vivo biomarker concentrations in biological matrices such as blood or urine. This guidance does not apply to bioanalytical method validations for the measurement of veterinary drug concentrations or veterinary biomarker concentrations.