FDA Guidance Documents
Technotes
Stay current with the latest FDA guidance documents affecting drug, biologic, device, and diagnostic development. Browse recently issued and updated guidance to identify evolving regulatory expectations, compliance considerations, and recommendations that may influence your development and testing strategies.
This guidance document provides the FDA’s recommendations on information to support premarket submissions for patient-matched guides for orthopedic implants. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions for patient-matched guides for orthopedic implants. This document also provides recommendations that manufacturers...
This 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. In general, FDA’s guidance documents do not establish legally enforceable responsibilities....
For a high-level overview of this guidance document, please watch this recorded webinar featuring Kimberly Schultz, PhD (Office of Therapeutic Products, FDA) and LCDR Jessica Dunn, PhD (Office of Compliance and Biologics Quality, FDA). This guidance describes how FDA applies flexibility to the chemistry, manufacturing, and controls (CMC) requirements for...
This guidance document is an annex to the parent guidance VICH GL3, “Stability Testing of New Veterinary Drug Substances and Medicinal Products.” It addresses the recommendations for stability testing of new veterinary medicinal Medicated Premix products intended for submission for approval to the European Union, Japan and the United States....
FDA is issuing this draft guidance to provide a proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) in accordance with 42 CFR part 84, specifically: surgical N95 respirators and N95 filtering facepiece...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Establishing Impurity Specifications for Antibiotics.” The draft guidance provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactured by fermentation and semi-synthesis. This draft guidance applies to...
This guidance provides information for industry, researchers, physicians, institutional review boards, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (21 CFR part 312, subpart I), which went into effect on October 13, 2009. FDA received...
For a high-level overview of this guidance document, please watch this recorded webinar featuring Komudi Singh, PhD from FDA’s Office of Therapeutic Products. This 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...
This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), as applicable, to validate bioanalytical methods used to evaluate biomarker concentrations. This guidance can also inform...
FDA is issuing this guidance to provide recommendations on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA. This guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit PPI to...
