US FDA guidance for industry April – June 2026

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
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.