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 regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions (e.g., Premarket Approval (PMA) Applications, Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo classification requests). The guidance also...
This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar...
This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar products,...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” This guidance is intended for foreign and domestic human and animal drug manufacturing establishments inspected by...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines.” The guidance was prepared under the auspices of the International Council...
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical...
The purpose of this guidance is to describe considerations for generating substantial evidence of effectiveness and evidence of safety for individualized therapies based on a plausible mechanism framework. The plausible mechanism framework outlines a set of recommendations to help developers of individualized therapies generate sufficient clinical safety and efficacy data...
This guidance is intended for sponsors of approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) containing antimicrobial drugs: (1) important to human medicine (medically important antimicrobial drugs), (2) for use in or on the medicated feed of food-producing animals, and (3) that are currently approved...
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Certification Process for Designated Medical Gases.” This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs). Specifically, the guidance discusses...
