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.
The 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 Food and Drug Administration’s (FDA’s or Agency’s) current recommendations regarding the overall development program and clinical trial designs for the development of drugs...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Local Anesthetic Drug Products With Prolonged Duration of Effect.” The draft guidance reflects the Agency’s current recommendations regarding drug development and trial design issues relevant to the study of...
This 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 the Food and Drug Administration (FDA) to issue or update existing guidance to help address challenges to developing...
The purpose of this guidance is to describe the benefit-risk assessment framework that the 17 Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for 18 approval under section 505 of the Federal Food, Drug, and Cosmetic Act. This guidance 19 summarizes the information that should...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “Pulmonary Tuberculosis: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention." The purpose of this guidance is to assist sponsors in the clinical development of drugs to support an indication...
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance for industry titled “Postapproval Pregnancy Safety Studies.” The purpose of this guidance is to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to...
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...
