FDA Guidance Documents
FDA Guidance Documents
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.
We, FDA, are providing you, blood establishments that collect blood and blood components, including Source Plasma, with recommendations for testing blood and blood components for hepatitis B virus (HBV) to reduce the risk of transfusion-transmitted HBV. The recommendations contained in this guidance apply to the collection of Whole Blood and...
This guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. We, the FDA, are issuing this guidance to assist you (manufacturers, applicants, and other stakeholders) in developing approaches for assuring the potency of CGT...
This question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementation of the ICH guidances for industry E14 "Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs" (October 2005) and S7B "Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products." This revised draft guidance revises and replaces the draft guidance entitled "Essential Drug Delivery Outputs Intended...
FDA is issuing this draft guidance document for sponsors of Investigational Device Exemption (IDE) applications to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those sponsors to current publicly available resources and associated content developed to support the electronic submission...
This draft guidance is for sponsors and applicants developing individualized genome editing products, which tailor editing components to each patient's specific pathogenic gene variant. It explains how multiple product variants can be submitted in one Biologics License Application under section 351(a) of the PHS Act, how to define the permissible...
This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and...
This final guidance gives technical specifications for submitting clinical trial data from driving studies that support marketing applications for drugs or biological products. These studies mainly assess psychoactive drugs, though some non-psychoactive drugs may also be studied. This guidance accompanies, and does not replace, FDA's November 2017 guidance Evaluating Drug...
This guidance helps small businesses understand and comply with FDA's safety reporting regulations for drugs and biological products under an investigational new drug application (IND), and for drugs in certain exempt bioavailability (BA) and bioequivalence (BE) studies. The guidance page was refreshed in October 2026 and now lists Center for...
This guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in Title 21 of the...
